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Generic

Mayra Liz Guzman-kaslow

Orlando,FL

Summary

I am a seasoned professional with over 36 years of diverse expertise with proficiency in spearheading complex sterile manufacturing, diverse-scale media operations, and initiating successful plant start-ups for Pharmaceuticals, APIs, Biotech, Biosimilars, Cell and Gene Therapy, Contract Development Manufacturing Operations / Contract Manufacturing Operations Organizations, and Medical Devices. Notable achievements include A process of improvement, Quality oversight (shop floor), and remediation, with a record of establishing effective manufacturing procedures that have increased the quality of deliverables. Accurately evaluate the quality of sterile manufacturing processes, Large- and small-scale media operations, and the manufacturing of drug substances and products. Recruit diverse, highly skilled teams of quality systems experts to evaluate, identify shortfalls, and develop comprehensive solutions proven to achieve success and meet FDA, EMEA, and HPFB1 regulations. Consistently increase staff effectiveness by executing performance reviews and developing personalized professional development plans. Furthermore, I have a proven track record in Regulatory Affairs, Regulatory Labeling, Regulatory Compliance, Quality Systems, Design Controls, Quality System Regulation (QSR), Quality Control, Quality Assurance, GAP analysis, and extensive experience in responding to FDA-483, Warning Letters, and Consent Decrees, and conducting remediation work. My strengths lie in strategic planning, Quality Program implementation, SOP development, consistently meeting goals, and delivering sustained high-level performance. I also excel in building strong customer/client relationships, including conducting vendor audits and overseeing contract manufacturing. Knowledgeable in Regulatory Compliance, Quality Systems, and Regulatory Affairs with a strong background in managing plant operations and optimizing production processes. Successfully led initiatives that improved workflow efficiency and reduced downtime. Demonstrated leadership and problem-solving skills through effective team management and continuous process improvement.

Overview

35
35
years of professional experience
1
1
Certificate

Work History

Quality Assurance Auditor

Allergan Pharmaceuticals
06.2024 - 03.2025
  • Responsible for reviewing, translating, and remediating any necessary reported observations of the past GMP ANVISA Audit and supporting the incoming Audit team.
  • Drug Manufacturer
  • Scheduled and executed yearly audits.
  • Promoted critical thinking by designing challenging assignments that required students to analyze and synthesize information.
  • Implemented differentiated instruction techniques to accommodate various learning styles and abilities within the classroom.
  • Evaluated student progress regularly, providing timely feedback for continuous improvement in academic performance.
  • Continually pursued professional development opportunities to stay current with educational trends and research, ensuring high-quality instruction for all students.
  • Established a positive learning environment by fostering strong relationships with students, parents, and colleagues.
  • Maintained accurate records of student performance, using data-driven analysis to inform instructional decisions.
  • Organized and participated in extracurricular activities that fostered a sense of community and enriched the educational experience for students outside the classroom setting.
  • Installed, configured, and monitored new system features based on user needs.
  • Optimized customer experience by delivering superior services and effectively troubleshooting issues.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Devised and implemented processes and procedures to streamline operations.
  • Developed effective improvement plans in alignment with goals and specifications.
  • Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
  • Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
  • Generated reports detailing findings and recommendations.
  • Educated staff on organizational mission and goals to help employees achieve success.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Evaluated staff performance and provided coaching to address inefficiencies.
  • Collected, arranged, and input information into database system.
  • Maintained database systems to track and analyze operational data.
  • Helped meet changing demands by recommending improvements to business systems or procedures.
  • Created and managed project plans, timelines and budgets.
  • Compared quantity, quality and labeling of customer orders to check accuracy and completeness.
  • Enhanced product quality by conducting thorough audits and identifying areas for improvement.
  • Gathered and reviewed current data to determine areas in need of improvement.
  • Educated and oriented employees to improve compliance with quality control protocols.
  • Completed timely quality reports highlighting deficiencies and recommending corrective actions.
  • Inspected work areas regularly to identify safety practices, quality control procedures and worker actions in need of improvement.
  • Determined correct procedures for inspection and review to standardized audit processes.
  • Identified issues of non-compliance and elevated reports to senior personnel.
  • Trained and reviewed work of junior personnel on departmental responsibilities.
  • Performed continuous random spot reviews of daily log pages, non-routine and work package contents for completeness, correct use of appropriate references and approved data.
  • Monitored departmental forms for compliance to submissions rules and guidelines.
  • Conducted organizational safety program reviews per department protocols.
  • Compiled clinical research data into audit reports and shared with research teams and lead investigators.
  • Reviewed and resolved issues raised during release of API, Safety Assessment or clinical supply lots for conformance to appropriate regulatory requirements.
  • Verified manufacturing team compliance with quality control processes to help minimize rework and keep costs low.
  • Maintained meticulous clinical trial documentation to show compliance with institutional policies and federal regulations.
  • Participated in compliance inquiries and provided interpretation of data to guide investigators in creation of Corrective and Preventive Actions.
  • Helped maximize output quality by approving production tests and specifications in advance and communicating required changes to supervisors.
  • Audited activities of workers on production lines and shipping and receiving.

Plant Manager

LeaRis KN Life Science
11.2022 - 12.2023
  • Support the start-up of the entire operations of a manufacturing plant. This includes managing and coordinating daily activities to ensure high performance and production. Other duties include ensuring company policies and procedures are followed, assisting in the onboarding process of new hires, and providing training and educational materials to staff members.
  • Drug Manufacturing Start-Up
  • Developed strong relationships with suppliers, ensuring timely delivery of raw materials for uninterrupted production.
  • Enhanced product quality by establishing rigorous quality control measures and training plant staff on best practices.
  • Implemented safety procedures to decrease workplace accidents and maintain a safe working environment for all employees.
  • Enhanced employee performance with comprehensive training programs, regular evaluations, and constructive feedback.
  • Oversaw maintenance activities, ensuring optimal equipment functionality, which minimized unplanned downtime.
  • Managed capital investment projects effectively from conception through completion while staying within budget constraints.
  • Increased production efficiency by optimizing plant layout and implementing process improvements.
  • Reduced costs by eliminating materials waste and unnecessary labor hours.
  • Directed employees and related programs to maximize team productivity and facility output.
  • Provided direction and leadership to all levels of employees and managers.
  • Boosted employee morale and productivity through effective leadership and motivational techniques.
  • Led, trained and coached plant staff to facilitate high levels of productivity and quality.
  • Monitored and evaluated plant performance to identify areas for improvement and take corrective measures.
  • Balanced labor needs with production schedules to optimize workforce utilization while maintaining output targets.
  • Maximized plant safety through proactive strategies and well-structured training.
  • Created plant policies and procedures for safe and productive operations.
  • Forecasted future production needs accurately, allowing for strategic decision-making regarding staffing levels, equipment investments, and inventory management.
  • Mentored and developed staff members, promoting professional growth opportunities within the organization.
  • Maintained quality of product with robust inspections and assessment team.
  • Managed direction and planning for plant with focus on optimization of daily functions, exceeding customer expectations, and achieving KPIs.
  • Collaborated with sales team to align plant capabilities with customer demands, fostering long-term business relationships.
  • Implemented quality control measures to reduce defect rates and enhance product quality consistently.
  • Implemented useful inventory management and tracking systems to reduce costs and improve operations.
  • Reduced downtime for maintenance by establishing a proactive preventive maintenance program.
  • Conducted thorough root cause analyses on production issues, identifying solutions for continuous improvement efforts.
  • Identified and resolved process and equipment issues to minimize production downtime.
  • Promoted collaborative work environment to motivate and engage staff to achieve company objectives.
  • Analyzed incident reports to identify trends in workplace injuries or near-misses; implemented corrective actions accordingly.
  • Managed budgeting and resource allocation, ensuring optimal use of funds for operational efficiency.
  • Established positive relationships with suppliers to obtain timely deliveries of materials and products.
  • Identified and implemented viable strategies for continuous improvement.
  • Built strong relationships with regulatory agencies and ensured compliance with all environmental permits; maintained an exemplary safety record.
  • Streamlined supply chain operations, reducing lead times and improving inventory management.
  • Developed cross-functional teams to foster collaboration and improve communication across departments.
  • Enhanced safety standards with implementation of comprehensive safety training initiatives for all employees.
  • Coordinated plant expansions and upgrades to accommodate increased demand while minimizing disruption to ongoing operations.
  • Negotiated favorable contracts with suppliers, securing cost savings on raw materials without sacrificing quality.
  • Collaborated with engineering team to design new machinery, resulting in increased production capacity.
  • Championed sustainable practices throughout the facility, implementing waste reduction strategies and energy-efficient technologies.
  • Boosted team morale and efficiency through leadership and development initiatives.
  • Coordinated with sales department to align production with market demand.
  • Developed training programs to upskill workforce and improve productivity.
  • Streamlined inventory management to reduce waste and optimize stock levels.
  • Achieved significant cost savings by negotiating better rates with suppliers.
  • Fostered culture of safety, significantly reducing workplace accidents.
  • Established metrics to measure performance and drive continuous improvement.
  • Optimized resource allocation for increased operational efficiency.
  • Improved product quality by implementing rigorous quality control measures.
  • Reduced downtime with proactive maintenance schedules.
  • Led introduction of new technology to automate and improve production processes.
  • Spearheaded initiatives to improve employee engagement and job satisfaction.
  • Facilitated cross-departmental collaboration to improve overall plant performance.
  • Implemented sustainable practices, reducing environmental impact.
  • Enhanced plant productivity by streamlining operational processes.
  • Negotiated with vendors for timely delivery of raw materials, preventing production delays.
  • Pioneered lean manufacturing approach, reducing unnecessary costs and increasing efficiency.
  • Managed budget effectively, ensuring optimal use of resources.
  • Enhanced communication between shifts, ensuring smooth handovers and continuity.
  • Managed personnel by implementing company policies, procedures, work rules, and disciplinary action.
  • Enforced health and safety protocols to promote safe working environment.
  • Evaluated employee performance and provided feedback and training as needed.
  • Created and oversaw production schedules and adjusted as needed to meet deadlines.
  • Oversaw routine maintenance programs and scheduled service to keep equipment functioning at peak levels.
  • Planned operations to meet established schedules, factoring in order demands and business forecasts.
  • Coordinated with other departments to align production with customer requirements.
  • Analyzed production data and prepared reports for senior management.
  • Utilized data analysis tools to identify and resolve production issues.
  • Implemented quality control system to review products against technical specifications and corporate standards.
  • Monitored inventory levels and restocking schedules to avoid production delays from unavailable materials.
  • Scrutinized production output and identified areas for improvement.
  • Updated logs and submitted timely reports detailing activities in line with regulatory standards.
  • Researched latest industry trends and technologies, boosting knowledge and understanding of industrial production.
  • Trained in and implemented emergency response procedures to protect team members and property.
  • Collaborated with technical and administrative teams to develop and implement successful corrective plans.
  • Operated specialized equipment, gauges and instruments to track and assess gas levels.
  • Checked meters and interpreted readings to assess functionality of gas retrieval systems.

Head of Quality and Regulatory

Geniuxs Pharmaceuticals
04.2022 - 10.2022
  • Responsible for the implementation of Quality Management Systems (QMS) for the Parenteral/Sterile Manufacturing Startup. In addition, support the company, regulatory compliance system, and vendor audit activities as needed and included oversight of the document preparation, pre-review, and discussion with appropriate personnel including the Document Control Group in readiness and response. Acted as the SME lead and directed all QA activities supporting Facility Engineering and Equipment Validation Fill and Finished Isolators in a complex sterile manufacturing organization setting.
  • Consultant Role
  • Developed comprehensive training programs for new hires, resulting in increased efficiency and knowledge among staff members.
  • Coordinated recall efforts when necessary, collaborating with internal stakeholders as well as external partners to ensure effective communication and resolution strategies were employed.
  • Championed a culture of continuous improvement by fostering open communication channels between employees at all levels within the organization.
  • Collaborated with suppliers to establish stringent quality criteria for incoming materials, enhancing overall product consistency.
  • Ensured compliance with industry regulations by staying up-to-date on changing standards and providing guidance across multiple departments.
  • Improved product quality by implementing rigorous inspection processes and updating standard operating procedures.
  • Reduced waste by optimizing manufacturing processes, increasing overall production efficiency while maintaining high-quality output.
  • Served as a primary point of contact for regulatory agencies during inspections and audits, demonstrating the company''s commitment to compliance and continuous improvement.
  • Oversaw the maintenance of ISO 9001 certification by ensuring continuous process improvements within the organization.
  • Increased customer satisfaction through timely response to inquiries, thorough investigation of issues, and implementation of corrective actions as needed.
  • Enhanced employee engagement in quality initiatives by recognizing individual contributions and promoting a culture of accountability.
  • Led a team of quality assurance professionals, ensuring consistent adherence to company standards and regulatory requirements.
  • Implemented Six Sigma methodologies throughout various departments, resulting in improved operational efficiencies and reduced process variability.
  • Streamlined quality control processes by integrating automated systems and reducing manual inspection tasks.
  • Initiated cross-functional collaborations with engineering and manufacturing teams to identify root causes of defects and implement corrective actions.
  • Managed the resolution of customer complaints, leading investigations to determine cause and implementing corrective actions to prevent recurrence.
  • Developed and maintained comprehensive documentation of quality processes, ensuring consistent adherence to established procedures across all departments and teams.
  • Conducted regular audits of production processes, identifying areas for improvement and implementing changes to enhance overall product quality.
  • Managed and archived quality documentation and participated in internal and external quality audits.
  • Updated quality control standards, methods, and procedures to meet compliance requirements.
  • Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
  • Evaluated quality problems and performed assessments to identify and resolve issues.
  • Increased customer satisfaction through adherence to quality standards and customer requirements.
  • Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
  • Mentored and encouraged employees to strive for excellence while fostering professional growth.
  • Wrote and implemented new rework procedures to standardize processes and streamline workflow.
  • Improved quality processes for increased efficiency and effectiveness.
  • Inspected inbound and outbound products for compliance with established industry standards, company policies, and procedures.
  • Devised specifications for processes.
  • Calibrated instruments and scales in production area and quality lab.
  • Developed and deployed production control plans and created work instructions and procedures.
  • Sorted product and provided expertise on non-conforming product requirements.
  • Provided observations, took measurements, and performed tests at various stages according to quality control plan.
  • Liaised with HR manager to organize and perform quality standard training for new and existing staff.
  • Established and tracked quality department goals and objectives.
  • Monitored staff organization and suggested improvements to daily functionality.
  • Tracked quality issues with external customers, suppliers, and internal plant operations.
  • Recorded, analyzed, and distributed statistical information.
  • Determined quality department standards, practices, and procedures.
  • Applied coaching techniques and tools to support managers and team members in improving performance.
  • Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
  • Inspected products and worker progress throughout production.
  • Implemented new quality assurance and customer service standards.
  • Assured consistent quality of production by implementing and enforcing automated practice systems.
  • Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
  • Reported production malfunctions to managers and production supervisors.
  • Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
  • Specified quality requirements of raw materials with suppliers.
  • Evaluated vendor performance through routine assessments, recommending adjustments or replacements as necessary to maintain optimal supply chain relationships.

Head of Quality Continuous Flow-Manufacturing

Brightpath Laboratories
08.2021 - 04.2022
  • Responsible for overseeing the end-to-end manufacturing process to ensure uninterrupted product production. Additionally, I managed the start-up operations within the manufacturing function, supported the manager with daily operations, supervised a team, and ensured efficient operations to meet business targets.
  • Consultant Role
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Learned and adapted quickly to new technology and software applications.
  • Self-motivated, with a strong sense of personal responsibility.
  • Worked effectively in fast-paced environments.
  • Skilled at working independently and collaboratively in a team environment.
  • Proven ability to learn quickly and adapt to new situations.
  • Excellent communication skills, both verbal and written.
  • Worked well in a team setting, providing support and guidance.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.
  • Passionate about learning and committed to continual improvement.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Organized and detail-oriented with a strong work ethic.
  • Paid attention to detail while completing assignments.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Strengthened communication skills through regular interactions with others.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Developed and maintained courteous and effective working relationships.
  • Led a team of quality assurance professionals, ensuring consistent adherence to company standards and regulatory requirements.
  • Streamlined quality control processes by integrating automated systems and reducing manual inspection tasks.
  • Oversaw the maintenance of ISO 9001 certification by ensuring continuous process improvements within the organization.
  • Championed a culture of continuous improvement by fostering open communication channels between employees at all levels within the organization.
  • Evaluated vendor performance through routine assessments, recommending adjustments or replacements as necessary to maintain optimal supply chain relationships.
  • Increased customer satisfaction through timely response to inquiries, thorough investigation of issues, and implementation of corrective actions as needed.
  • Managed the resolution of customer complaints, leading investigations to determine cause and implementing corrective actions to prevent recurrence.
  • Collaborated with suppliers to establish stringent quality criteria for incoming materials, enhancing overall product consistency.
  • Developed comprehensive training programs for new hires, resulting in increased efficiency and knowledge among staff members.
  • Improved product quality by implementing rigorous inspection processes and updating standard operating procedures.
  • Implemented Six Sigma methodologies throughout various departments, resulting in improved operational efficiencies and reduced process variability.
  • Ensured compliance with industry regulations by staying up-to-date on changing standards and providing guidance across multiple departments.
  • Enhanced employee engagement in quality initiatives by recognizing individual contributions and promoting a culture of accountability.
  • Developed and maintained comprehensive documentation of quality processes, ensuring consistent adherence to established procedures across all departments and teams.
  • Coordinated recall efforts when necessary, collaborating with internal stakeholders as well as external partners to ensure effective communication and resolution strategies were employed.
  • Conducted regular audits of production processes, identifying areas for improvement and implementing changes to enhance overall product quality.
  • Served as a primary point of contact for regulatory agencies during inspections and audits, demonstrating the company''s commitment to compliance and continuous improvement.
  • Initiated cross-functional collaborations with engineering and manufacturing teams to identify root causes of defects and implement corrective actions.
  • Reduced waste by optimizing manufacturing processes, increasing overall production efficiency while maintaining high-quality output.
  • Managed and archived quality documentation and participated in internal and external quality audits.
  • Updated quality control standards, methods, and procedures to meet compliance requirements.
  • Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
  • Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
  • Evaluated quality problems and performed assessments to identify and resolve issues.

CEO General Manager

GK Pharmaceuticals CDMO
12.2016 - 07.2021
  • Works closely with the Board of Directors, serving as managing director of corporate operations and as the main link between the different divisions within the company. Responsible for driving the site start-up toward long-term success. The company’s development guide is.
  • Start-Up
  • Achieved company growth by implementing strategic plans and streamlining operations.
  • Managed partnerships and strategic business relationships by negotiating contract terms and handling conflicts.
  • Developed key operational initiatives to drive and maintain substantial business growth.
  • Created a positive work culture, resulting in increased employee satisfaction and retention rates.
  • Built productive relationships with industry partners and competitors to support strategic business objectives.
  • Established new revenue streams by identifying market opportunities and launching innovative products or services.
  • Streamlined business processes, resulting in increased operational efficiency across all departments.
  • Developed a high-performance executive team for improved productivity and efficiency.
  • Optimized supply chain operations for reduced costs and increased efficiency.
  • Improved organizational structure by reallocating resources and redefining roles for greater efficiency.
  • Developed a high-performing executive team by recruiting top talent and implementing comprehensive training programs.
  • Achieved remarkable year-over-year revenue growth through strategic product diversification and market analysis.
  • Established and maintained strong relationships with customers, vendors, and strategic partners.
  • Managed financial, operational, and human resources to optimize business performance.
  • Analyzed industry trends and tracked competitor activities to inform decision making.
  • Developed innovative sales and marketing strategies to facilitate business expansion.
  • Formulated and executed strategic initiatives to improve product offerings.
  • Created succession plans to provide continuity of operations during leadership transitions.
  • Devised and presented business plans and forecasts to the board of directors.
  • Monitored key business risks and established risk management procedures.
  • Managed budget implementations, employee reviews, training, schedules, and contract negotiations.
  • Managed a diverse team of professionals, fostering a positive work environment and high employee satisfaction.
  • Developed and implemented strategies to increase sales and profitability.
  • Managed budget development, forecasting, and financial reporting processes to track progress towards organizational objectives accurately.
  • Formulated policies and procedures to streamline operations.
  • Implemented operational strategies and effectively built customer and employee loyalty.
  • Managed budget implementations, employee evaluations, and contract details.
  • Increased overall company efficiency by streamlining operations and implementing innovative managerial strategies.
  • Established comprehensive employee training programs to develop skills, improve productivity, and maintain compliance with industry regulations.
  • Developed and executed strategic plans for business growth and expansion, resulting in increased market share.
  • Analyzed market trends/data to identify potential opportunities for business growth within existing or emerging markets successfully.
  • Developed and executed a comprehensive employee training program, elevating staff skills and improving service delivery.
  • Improved operational efficiency by streamlining workflow processes and adopting cutting-edge technology.
  • Managed purchasing, sales, marketing, and customer account operations efficiently.
  • Updated and resolved incidents and managed accessorize charges objectively while maximizing profit.
  • Identified and qualified customer needs and negotiated and closed profitable projects with a high success rate.
  • Launched staff engagement, gender diversity, and cultural programs in addition to a robust reporting tool that increased operational quality.

Owner - Quality Management System SME

GK Regulatory Compliance
08.2005 - 12.2016
  • As the Quality Assurance Regulatory Compliance Subject Matter Expert (SME) Responsible for managing the company, regulatory compliance system, and vendor audits as needed. This may include oversight of the document preparation, pre-review, and discussion with appropriate personnel including the Document Control Group in readiness and response. Also, as the SME lead and direct all QA activities supporting Facility Engineering and Validation in a contract manufacturing organization setting. Direct the review and approval processes, resulting in timely QA oversight of equipment, computer systems, utilities, and facilities. Provide quality oversight of facility upgrades and expansions.
  • Developed and maintained strong relationships with clients, resulting in repeat business and referrals.
  • Oversaw daily operations, ensuring all tasks were completed accurately and efficiently by team members.
  • Increased customer satisfaction by implementing efficient business processes and providing exceptional service.
  • Consulted with customers to assess needs and propose optimal solutions.
  • Trained and motivated employees to perform daily business functions.
  • Implemented marketing strategies to increase brand awareness and attract new customers.
  • Hired trained, and managed a high-performing team of employees dedicated to achieving company goals.
  • Managed financial aspects of the business, including budgeting, financial reporting, and tax preparation.
  • Established a positive workplace culture that fostered employee engagement, collaboration, and loyalty.
  • Negotiated contracts with suppliers for better pricing and terms, reducing overall costs for the business.
  • Established foundational processes for business operations.
  • Achieved financial growth with strategic planning, cost control measures, and targeted marketing efforts.
  • Organized and attended trade shows and special events to showcase products, network with other businesses and attract new customers.
  • Enhanced operational efficiency and productivity by managing budgets, accounts, and costs.
  • Evaluated industry competition regularly to maintain a competitive advantage in the marketplace.
  • Successfully navigated challenging economic conditions by making informed decisions that protected the business''s financial stability.
  • Monitored market conditions to set accurate product pricing and take advantage of emerging trends.
  • Ensured regulatory compliance by staying abreast of industry-related changes and implementing necessary policies or procedures as needed.
  • Mentored staff members on best practices in customer service and sales techniques, leading to increased performance levels.
  • Expanded product offerings by researching market trends and identifying potential growth opportunities.
  • Generated revenues yearly and effectively capitalized on industry growth.
  • Streamlined operations to improve efficiency, enabling more time to be spent on strategic planning and decisionmaking.
  • Enhanced company's market position by identifying and pursuing new business opportunities.
  • Fostered strong relationships with clients to boost retention rates, conducting regular feedback sessions.
  • Developed and implemented strategic plans for revenue growth, focusing on diversification and market expansion.
  • Led negotiations for major contracts, securing favorable terms that significantly reduced costs.
  • Improved team productivity by introducing innovative project management tools and techniques.
  • Achieved significant cost savings by implementing energy-efficient solutions across company facilities.
  • Streamlined operational processes to improve efficiency with comprehensive audits and restructuring.
  • Expanded business into new markets, cond
  • Elevated brand awareness with targeted marketing campaigns, leveraging social media and digital platforms.
  • Optimized supply chain operations, negotiating with suppliers to ensure timely delivery of high-quality products.
  • Interacted well with customers to build connections and nurture relationships.
  • Managed purchasing, sales, marketing and customer account operations efficiently.
  • Negotiated price and service with customers and vendors to decrease expenses and increase profit.
  • Implemented business strategies, increasing revenue, and effectively targeting new markets.
  • Handled problematic customers and clients to assist lower-level employees and maintain excellent customer service.
  • Cultivated and strengthened lasting client relationships using strong issue resolution and dynamic communication skills.
  • Assisted in recruiting, hiring and training of team members.
  • Scheduled employees for shifts, taking into account customer traffic and employee strengths.
  • Recruited, hired, and trained initial personnel, working to establish key internal functions and outline scope of positions for new organization.
  • Managed day-to-day business operations.

Quality System Improvement Specialist

Intas Pharmaceuticals
03.2016 - 11.2016
  • Responsible for the improvement of site Quality System Requirements and FDA, ANVISA, and MHRA compliance readiness. In addition to overseeing quality activities such as SOP revisions, proposed system changes to comply with GMP requirements, including Knowledge Transfer and Training. Also, support the Regulatory Affairs Department with the review and submission of the new product (Biosimilar for oncology treatment).
  • Biotech and Cell & Gene Therapy Plant
  • Followed all company policies and procedures to deliver quality work.
  • Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
  • Collaborated with cross-functional teams to achieve project goals on time and within budget.
  • Implemented new training programs for staff, leading to higher employee retention rates and better overall performance.
  • Championed the adoption of new software tools that streamlined workflows across multiple departments.
  • Enhanced customer satisfaction with timely and accurate issue resolution.
  • Initiated sustainability program, reducing company's environmental impact.
  • Streamlined project delivery processes, reducing completion times significantly.
  • Coordinated with IT department to upgrade cybersecurity measures, safeguarding company data.
  • Developed training materials to enhance staff proficiency and productivity.
  • Boosted company's online presence by developing comprehensive digital marketing strategy.
  • Conducted in-depth market research for identifying new business opportunities.
  • Designed employee recognition program that improved morale and reduced turnover.
  • Conducted comprehensive competitor analysis to inform strategic decisions.
  • Negotiated with suppliers to reduce material costs, improving profit margins.
  • Facilitated workshops for professional development of junior staff members.
  • Led quality assurance efforts, maintaining high standards for all products and services.
  • Improved team collaboration by initiating regular strategy meetings.
  • Led cross-functional team to launch new product, exceeding initial sales forecasts.
  • Implemented customer feedback system to inform product development.
  • Analyzed sales data to identify trends and adjust marketing strategies accordingly.
  • Optimized inventory management, minimizing waste and reducing costs.
  • Increased efficiency by automating routine tasks with software solutions.
  • Assisted in developing strategic plan that aligned with long-term company goals.
  • Restructured customer service process, ensuring quicker response times.
  • Optimized customer experience by delivering superior services and effectively troubleshooting issues.
  • Gathered, organized and input information into digital database.
  • Collected, arranged, and input information into database system.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Generated reports detailing findings and recommendations.
  • Helped meet changing demands by recommending improvements to business systems or procedures.
  • Maintained database systems to track and analyze operational data.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
  • Developed effective improvement plans in alignment with goals and specifications.
  • Created and managed project plans, timelines and budgets.
  • Devised and implemented processes and procedures to streamline operations.
  • Evaluated staff performance and provided coaching to address inefficiencies.
  • Frequently inspected production area to verify proper equipment operation.
  • Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
  • Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
  • Supported creation of detailed, technical financial models to value potential acquisition targets.
  • Observed packing operations to verify conformance to specifications.

Sr. Project Manager

Gilead Science Corp.
07.2015 - 03.2016
  • Responsible for the overall project management for the Gilead New Quality Control and Warehouse start-up, commissioning, and qualification project. In addition, manage the Quality System implementation ensuring the meeting of ANVISA regulations at the new Gilead Brazil site by assessing the GMP activities to be held at the site, developing a project plan, and leading the implementation of the plan. Some of the activities included managing Senior QA Specialists, the review and approval of Policies, SOPs, Validation Documents, C&Q for the facility, utilities, equipment, and Laboratory instruments Validation.
  • Drug Manufacturer
  • Established effective communication channels with stakeholders to ensure transparency and alignment of expectations.
  • Developed comprehensive project plans, identifying risks and mitigation strategies for timely completion.
  • Developed and maintained project budgets to control costs and meet organizational and project goals.
  • Streamlined project management processes by implementing agile methodologies, resulting in improved efficiency and reduced costs.
  • Monitored project progress, identified risks and implemented corrective measures to acquire success.
  • Established and managed change management processes to fulfill successful project transitions.
  • Managed budgets exceeding $1 million while effectively controlling costs through diligent financial oversight.
  • Evaluated vendor proposals, selecting those that provided the best value for cost, quality, and timeliness.
  • Conducted post-project evaluations to identify areas of improvement and implement corrective actions for future endeavors.
  • Developed and led multi-disciplinary team to redefine problems and reach solutions based on different perspectives.
  • Spearheaded process improvement initiatives that resulted in increased productivity and streamlined workflows across departments.
  • Achieved substantial cost savings by renegotiating contracts with key suppliers and optimizing resource allocation across projects.
  • Established and maintained strong relationships with external stakeholders, including clients and partners, ensuring smooth project execution and new business opportunities.
  • Conducted detailed post-project evaluations to identify key learnings and areas for improvement, fostering culture of continuous improvement.
  • Developed comprehensive risk management plans to minimize project delays and budget overruns, safeguarding project outcomes.
  • Improved stakeholder communication by establishing regular update meetings and clear reporting channels, resulting in increased trust and partnership.
  • Developed and implemented project plans and budgets to ensure successful execution.
  • Monitored project progress, identified risks and took corrective action as needed.
  • Reported regularly to managers on project budget, progress, and technical problems.
  • Sourced, vetted and managed vendors needed to accomplish project goals.
  • Analyzed project performance data to identify areas of improvement.
  • Maintained schedules to meet key milestones at every project phase.
  • Directed changes to project scope and cost and implemented appropriate change management processes to keep project on track.
  • Presented regular status reports to executive leadership, providing insights into progress made toward achieving key milestones.
  • Mentored junior project managers and team members to enhance their skills and career growth.
  • Adapted quickly to unexpected challenges or obstacles encountered during project execution, devising creative solutions without compromising objectives.
  • Provided outstanding service to clients through effective communication and prompt issue resolution to facilitate future business opportunities.
  • Communicated project plans and progress to key stakeholders and project contributors.
  • Negotiated contracts with vendors and suppliers, securing favorable terms for the organization''s benefit.
  • Led cross-functional teams for successful project delivery within scope, schedule, and budget constraints.
  • Ensured compliance with industry regulations by staying current on changes in legislation or guidelines relevant to projects'' scopes.
  • Partnered with project team members to identify and quickly address problems.
  • Implemented change management processes to accommodate evolving project requirements while minimizing disruptions.
  • Coordinated cross-functional teams to determine timely delivery and compliance of project requirements.
  • Optimized resource allocation by closely monitoring project progress and adjusting team assignments as needed.
  • Championed innovative approaches when faced with complex problems or opportunities requiring non-traditional thinking.
  • Delivered high-quality results by fostering a culture of accountability among team members and setting clear performance expectations.
  • Crafted and maintained project plans and schedules to meet organizational objectives.
  • Nurtured strong working relationships with internal and external stakeholders, building trust and credibility that facilitated smooth collaboration on shared goals.
  • Oversaw large portfolio of projects to support teams, report progress, and influence positive outcomes for key stakeholders.
  • Monitored contracts and service level agreements to identify potential risks and implement mitigation actions to protect development process from unforeseen delays and costs.
  • Collaborated with business analysts to gather requirements, ensuring projects met client needs and expectations.
  • Optimized team performance and project outcomes by setting clear goals and expectations, coupled with regular performance reviews.
  • Enhanced client satisfaction and loyalty by delivering projects that consistently exceeded expectations in terms of quality, timeline, and budget.
  • Coordinated with regulatory bodies to ensure all projects complied with industry standards and regulations, mitigating legal and financial risks.
  • Oversaw development and implementation of training programs for junior project managers, building pipeline of future leaders.
  • Negotiated conflicts within project teams to ensure smooth project execution and maintain high morale.
  • Cultivated culture of innovation within project teams, encouraging exploration of new ideas and approaches to problem-solving.
  • Led cross-functional teams in successful completion of multimillion-dollar projects, ensuring they met all scope, time, and budget requirements.
  • Facilitated knowledge sharing and skill development workshops for project team members, enhancing team capabilities and project outcomes.
  • Drove organizational change by leading implementation of strategic initiatives, achieving significant improvements in business processes and efficiency.
  • Pioneered use of data analytics in project management, enabling more informed decision-making and strategic planning.
  • Streamlined project delivery timelines by implementing agile methodologies, significantly enhancing team productivity and client satisfaction.
  • Spearheaded adoption of sustainable practices in project execution, reducing environmental impact and promoting corporate social responsibility.
  • Enhanced team collaboration and efficiency with introduction of cutting-edge project management software.
  • Successfully recovered projects at risk of failure, implementing turnaround strategies that restored client confidence and secured project objectives.
  • Championed corporate values and ethics in all project activities, setting strong example for team members and reinforcing company's reputation for integrity.
  • Maintained open communication by presenting regular updates on project status to customers.
  • Tracked project and team member performance closely to quickly intervene in mistakes or delays.
  • Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
  • Verified quality of deliverables and conformance to specifications before submitting to clients.
  • Recruited and oversaw personnel to achieve performance and quality targets.
  • Facilitated workshops to collect project requirements and user feedback.

Quality Systems Implementation Champion - SME

Aerie Pharmaceuticals
06.2014 - 07.2015
  • Direct report to the VP of Regulatory Affairs and Quality. Oversee all the related quality assurance projects, including the implementation of Quality Systems. Performed Supplier Quality audits to ensure cGMP compliance. In addition, support the Regulatory Affairs activities such as reviewing the documentation in preparation for the submission package.
  • Drug Manufacturing
  • Enhanced product quality by implementing innovative process improvements and quality control measures.
  • Served as liaison between manufacturing and engineering departments, facilitating communication on product specifications and requirements.
  • Conducted regular audits to maintain adherence to established quality management system requirements.
  • Collaborated with cross-functional teams to develop robust processes, ensuring compliance with industry standards.
  • Established a strong working relationship with external auditors, streamlining assessment processes while addressing any gaps in compliance.
  • Championed lean initiatives within the organization, promoting waste reduction and overall process efficiency improvements.
  • Led process validation activities to ensure consistent production output while meeting all relevant guidelines.
  • Participated in regulatory inspections to demonstrate compliance with applicable standards and regulations.
  • Streamlined quality systems documentation for increased efficiency and ease of access.
  • Implemented risk-based thinking strategies for proactive identification and mitigation of potential issues.
  • Mentored junior team members on best practices in quality systems management, contributing to their professional growth.
  • Provided training on quality systems procedures, fostering a culture of continuous improvement within the organization.
  • Reduced non-conformance issues by conducting thorough root cause analysis and implementing corrective actions.
  • Improved customer satisfaction rates by addressing concerns promptly and effectively resolving issues.
  • Evaluated supplier performance through comprehensive assessments, maintaining high-quality vendor relationships.
  • Maintained an up-to-date knowledge base on industry advancements, incorporating new tools and techniques into the company''s practice.
  • Analyzed data trends for identification of recurring issues, leading efforts in finding long-term solutions.
  • Established and tracked quality department goals and objectives.
  • Monitored staff organization and suggested improvements to daily functionality.
  • Applied coaching techniques and tools to support managers and team members in improving performance.
  • Determined quality department standards, practices, and procedures.
  • Recorded, analyzed, and distributed statistical information.
  • Tracked quality issues with external customers, suppliers, and internal plant operations.

Complaint Coordinator

Maquet Getinge Group
10.2014 - 06.2015
  • Quality System Remediation. Site under Warning Letter. Work-stream and client contact for Operations readiness and sustainability for manufacturing facilities. Developed methodology for knowledge transfer program and directed work teams for twenty-seven (27) Consultants with a 24-hr/7-day work. responsible for the file’s remediation based on the gap assessments of MDD TFs to MDR, including support of open CAPAs and Complaint investigation.
  • Germany (Medical Devices)
  • Evaluated client needs and expectations, establishing clear goals for each consulting engagement.
  • Liaised with customers, management, and sales team to better understand customer needs and recommend appropriate solutions.
  • Collaborated with cross-functional teams to successfully deliver comprehensive solutions for clients.
  • Managed client relationships through regular check-ins and updates on project progress.
  • Enhanced communication among team members to foster collaborative and supportive work environment.
  • Assisted clients in navigating complex industry challenges with strategic recommendations.
  • Identified areas of improvement for clients'' operations, implementing targeted solutions to increase productivity.
  • Developed innovative strategies for clients, resulting in increased revenue and business growth.
  • Streamlined internal processes to enhance team efficiency and improve overall project outcomes.
  • Delivered high-quality presentations to stakeholders, effectively communicating project objectives and results.
  • Analyzed data sets to identify trends and opportunities for process improvements within client organizations.
  • Negotiated contracts on behalf of clients, securing favorable terms that contributed to their overall success.
  • Designed tailored training programs for employees at various levels within the organization, boosting overall skillsets.
  • Conducted thorough market research and analysis, providing valuable insights for client decisionmaking.
  • Collaborated with teams to define, strategize, and implement marketing and web strategies.
  • Implemented customer relationship management (CRM) systems, improving client engagement and retention rates.
  • Directed market entry strategies for clients looking to expand into new territories, ensuring compliance and cultural alignment.
  • Enhanced client decision-making, synthesizing complex data into clear, concise reports and dashboards.
  • Enhanced team productivity with implementation of agile methodologies, streamlining project delivery processes.
  • Conducted risk assessments for business processes, recommending measures to mitigate potential impacts.
  • Boosted client revenue streams by identifying and capitalizing on untapped market opportunities.
  • Increased client satisfaction by developing comprehensive consulting strategies tailored to each business's unique challenges and objectives.
  • Delivered comprehensive reports and presentations to stakeholders, providing insights and actionable recommendations for business improvement.
  • Streamlined communication processes for clients, enabling more effective collaboration and decision-making.
  • Analyzed financial data to identify cost-saving opportunities, advising clients on budget optimization strategies.
  • Conducted in-depth market research to identify emerging trends, enabling clients to adapt and stay ahead in competitive industries.
  • Improved organizational efficiency, overhauling outdated operational procedures with innovative, tech-driven solutions.
  • Optimized supply chain operations for clients, reducing costs and improving efficiency through strategic vendor management.
  • Facilitated workshops and training sessions for client staff, enhancing their skills and knowledge in key areas.
  • Negotiated contracts and agreements on behalf of clients, securing favorable terms and conditions.
  • Transformed client digital strategies, leveraging cutting-edge technologies to enhance online presence and customer interaction.
  • Coordinated with external partners and vendors to deliver comprehensive solutions that meet clients' diverse needs.
  • Developed and maintained strong client relationships, ensuring high levels of satisfaction and repeat business.
  • Established best practices for project management within client organizations, leading to more predictable and successful outcomes.
  • Led cross-functional teams in execution of strategic projects, fostering collaboration and ensuring alignment with corporate goals.
  • Maintained database systems to track and analyze operational data.
  • Optimized customer experience by delivering superior services and effectively troubleshooting issues.
  • Gathered, organized and input information into digital database.
  • Created and managed project plans, timelines and budgets.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Collected, arranged, and input information into database system.
  • Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
  • Generated reports detailing findings and recommendations.
  • Devised and implemented processes and procedures to streamline operations.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Developed effective improvement plans in alignment with goals and specifications.
  • Helped meet changing demands by recommending improvements to business systems or procedures.
  • Educated staff on organizational mission and goals to help employees achieve success.
  • Evaluated staff performance and provided coaching to address inefficiencies.
  • Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
  • Frequently inspected production area to verify proper equipment operation.
  • Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
  • Observed packing operations to verify conformance to specifications.
  • Supported creation of detailed, technical financial models to value potential acquisition targets.
  • Promoted critical thinking by designing challenging assignments that required students to analyze and synthesize information.
  • Evaluated student progress regularly, providing timely feedback for continuous improvement in academic performance.
  • Implemented differentiated instruction techniques to accommodate various learning styles and abilities within the classroom.
  • Continually pursued professional development opportunities to stay current with educational trends and research, ensuring high-quality instruction for all students.
  • Established a positive learning environment by fostering strong relationships with students, parents, and colleagues.
  • Maintained accurate records of student performance, using data-driven analysis to inform instructional decisions.
  • Organized and participated in extracurricular activities that fostered a sense of community and enriched the educational experience for students outside the classroom setting.
  • Installed, configured, and monitored new system features based on user needs.
  • Analyzed complaint data to identify root causes, trends, issues and regulatory concerns.
  • Conducted quality control reviews on complaint data and addressed results with colleagues to influence positive change.
  • Worked with stakeholders to help create and revise customer complaint monitoring, manage training and enforce policies and procedures.
  • Coordinated cross-functional teams to address systemic issues identified from analyzing complaint data patterns effectively.
  • Improved company reputation by providing exceptional customer service during the complaint resolution process.
  • Streamlined complaint processes for increased efficiency and quicker resolution times.
  • Established strong relationships with key internal partners including sales, marketing, product management teams to ensure seamless coordination while managing complex cases.
  • Contributed to policy development, ensuring all employees understood their roles in preventing and addressing complaints.
  • Trained new team members in proper complaint handling procedures, fostering a consistent approach across the organization.
  • Reduced repeat complaints by implementing preventative measures based on trends analysis.
  • Provided detailed reports on complaint statistics, identifying areas for improvement and recommending corrective actions.
  • Monitored industry trends to stay informed about emerging concerns that could impact customer satisfaction levels.
  • Prioritized urgent cases, ensuring prompt attention was given to mitigate potential escalations or legal issues.
  • Collaborated with various departments to identify root causes of complaints and develop effective solutions.
  • Increased resolution rates through effective communication with customers throughout the entire process.
  • Demonstrated empathy towards customers by actively listening to their concerns, exploring all possible avenues for resolution and providing clear explanations on the steps taken in each case.
  • Developed and maintained comprehensive complaint records, ensuring accurate tracking and reporting.
  • Conducted thorough investigations of complex issues to determine appropriate resolutions for customer satisfaction.
  • Tracked, monitored and worked with stakeholders to address issues identified through root cause analysis.
  • Promoted open lines of communication within the organization by providing regular updates on complaint statuses and outcomes.
  • Liaised with external stakeholders such as regulatory agencies when necessary, demonstrating transparency and professionalism during investigations.
  • Ensured compliance with relevant regulations pertaining to consumer protection laws while managing cases involving multiple jurisdictions.
  • Assisted with complaint gap analyses and risk assessments.
  • Enhanced customer satisfaction by diligently addressing and resolving complaints in a timely manner.
  • Evaluated existing procedures periodically to identify potential areas of improvement in the overall handling of customer complaints.
  • Investigated and resolved customer inquiries and complaints quickly.
  • Delivered exceptional customer service to every customer by leveraging extensive knowledge of products and services and creating welcoming, positive experiences.
  • Responded to customer requests, offering excellent support and tailored recommendations to address needs.
  • Delivered prompt service to prioritize customer needs.
  • Exhibited high energy and professionalism when dealing with clients and staff.
  • Met customer call guidelines for service levels, handle time and productivity.
  • Followed up with customers about resolved issues to maintain high standards of customer service.
  • Maintained up-to-date knowledge of product and service changes.
  • Educated customers about billing, payment processing and support policies and procedures.
  • Provided excellent customer care by responding to requests, assisting with product selection and handling ordering functions.
  • Responded proactively and positively to rapid change.
  • Promoted superior experience by addressing customer concerns, demonstrating empathy, and resolving problems swiftly.
  • Promptly responded to inquiries and requests from prospective customers.
  • Developed highly empathetic client relationships and earned reputation for exceeding service standard goals.
  • Collaborated with staff members to enhance customer service experience and exceed team goals through effective client satisfaction rates.
  • Trained new personnel regarding company operations, policies and services.
  • Managed timely and effective replacement of damaged or missing products.
  • Sought ways to improve processes and services provided.
  • Identified and resolved discrepancies and errors in customer accounts.
  • Cross-trained and provided backup support for organizational leadership.
  • Enhanced productivity levels by anticipating needs and delivering outstanding support.
  • Trained staff on operating procedures and company services.
  • Increased efficiency and team productivity by promoting operational best practices.
  • Calculated correct order totals, updated accounts, and maintained detailed records for inventory management.
  • Investigated and resolved accounting, service and delivery concerns.
  • Monitored cash drawers in multiple checkout stations and maintained adequate cash supply.
  • Followed-through on all critical inter-departmental escalations to increase customer retention rates.
  • Cross-trained and backed up other customer service managers.
  • Implemented and developed customer service training processes.
  • Liaised with sales, marketing, and management teams to develop solutions and accomplish shared objectives.
  • Maintained clean and orderly checkout areas by mopping floors, emptying trash cans and wiping down surfaces.
  • Increased efficiency and performance by monitoring team member productivity and providing feedback.
  • Optimized customer support by establishing collaborative service environments through targeted operational initiatives.
  • Recommended, selected and helped locate and obtain out-of-stock product based on customer requests.
  • Collected and returned unpurchased or returned items to correct shelf locations and arranged displays to promote sales.
  • Reduced process inconsistencies and effectively trained team members on best practices and protocols.
  • Resolved associate, tool and service delivery issues revealed by statistical reports.
  • Created and maintained detailed database to develop promotional sales.
  • Bolstered customer retention by creating and offering unique discount options and inspiring interest in new product lines.

Regulatory Compliance Auditor

DePuy Synthes
11.2013 - 06.2014
  • Sr. SME(WS6) Site under Warning Letter. In addition, part of the Regulatory Affairs Workstream. Responsible for conducting audits & routine inspections for compliance (21 CFR 820) as well as Process Compliance. In addition, responsible for performing specific verification of completion and verification of effectiveness audits of individual actions. Also, served as a Sr. Compliance resource embedded in the Regulatory Affairs Work Stream to help with the GRQ activities.
  • Johnson & Johnson Company (Medical Devices)
  • Collaborated with cross-functional teams to ensure timely implementation of corrective actions, mitigating potential compliance issues.
  • Analyzed all audit results and resolved all compliance issues.
  • Maintained up-to-date knowledge of regulatory changes affecting the business landscape, proactively adapting audit strategies as needed.
  • Improved financial transparency by providing clear communication of audit results to stakeholders through detailed reports and presentations.
  • Promoted ethical decision-making within the organization by serving as a trusted resource for addressing complex compliance questions or concerns.
  • Participated in various training and development programs.
  • Developed robust risk assessment frameworks to systematically identify, evaluate, and prioritize organizational risks.
  • Provided expert guidance on compliance requirements, ensuring informed decision-making across the organization.
  • Reduced financial risks through meticulous analysis of financial statements, internal controls, and operational procedures.
  • Delivered comprehensive training programs for employees on key compliance topics, fostering a sound understanding of relevant regulations and best practices.
  • Prepared reports for templates and maintained compliance database.
  • Conducted regular follow-up audits to verify that previously identified issues were effectively resolved or mitigated.
  • Supported the development of company-wide policies and procedures in alignment with industry standards and legal requirements.
  • Championed a proactive approach to risk management by identifying emerging trends, potential threats, and areas of opportunity for strengthening organizational resilience.
  • Facilitated open discussions with process owners regarding identified deficiencies, encouraging collaborative problem-solving efforts toward resolution.
  • Leveraged data analytics tools to enhance audit efficiency and accuracy, generating valuable insights to drive continuous improvement efforts.
  • Assessed third-party vendor relationships for compliance concerns, minimizing potential risks associated with external partnerships.
  • Developed key performance indicators for monitoring compliance activities, ensuring progress toward established objectives was effectively tracked and reported.
  • Evaluated the effectiveness of existing enterprise-wide risk management strategies in safeguarding organizational assets from potential threats or liabilities.
  • Strengthened overall corporate governance with comprehensive audit findings and actionable recommendations.
  • Fostered a culture of accountability by regularly monitoring adherence to regulatory guidelines and reporting non-compliance instances to senior management.
  • Streamlined internal processes by identifying inefficiencies in the existing control systems and recommending improvements.
  • Initiated comprehensive account assessments to check viability, stability, and profitability of business operations.
  • Provided journal entries and performed accounting on accrual basis.
  • Tracked funds, prepared deposits and reconciled accounts.
  • Collected and reported monthly expense variances and explanations.
  • Maintained integrity of general ledger and chart of accounts.
  • Prepared working papers, reports and supporting documentation for audit findings.
  • Trained new employees on accounting principles and company procedures.
  • Reviewed accounts, resolved coding areas, and tracked recurring expenses for accrual entry.
  • Compiled general ledger entries on short schedule with 100% accuracy.
  • Used accounting software to issue tax returns and prepare consolidated reports.
  • Cooperated with senior leaders to create operating budgets and initiate financial planning.
  • Kept up-to-date with tax changes and industry trends by participating in professional organizations, opportunities, and networks.
  • Collaborated with accounting manager to comply with governing bodies and limit regulatory risks.
  • Diminished outstanding debts by analyzing accounts for issues.
  • Developed financial models to assess and analyze financial performance of clients.
  • Identified legal tax savings and recommended ways to improve profits.
  • Found tax solutions to complicated tax issues or errors from incorrect tax filings.

QMS Remediation SME

McNeil Pharmaceuticals
04.2012 - 06.2013
  • Responsible for developing and leading the remediation strategy with the intent to exit the consent decree effort for the 2 pharmaceutical manufacturing sites in Fort Washington PA and Juncos, PR, including the key functional areas to govern, communicate, implement, and remediate processes to strengthen the organization in support the development and implementation of assigned quality system elements (QMS) and other consent decree activities.
  • J&J comp.)
  • Implemented differentiated instruction techniques to accommodate various learning styles and abilities within the classroom.
  • Evaluated student progress regularly, providing timely feedback for continuous improvement in academic performance.
  • Established a positive learning environment by fostering strong relationships with students, parents, and colleagues.
  • Organized and participated in extracurricular activities that fostered a sense of community and enriched the educational experience for students outside the classroom setting.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Devised and implemented processes and procedures to streamline operations.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Evaluated staff performance and provided coaching to address inefficiencies.
  • Collected, arranged, and input information into database system.
  • Created and managed project plans, timelines and budgets.
  • Developed effective improvement plans in alignment with goals and specifications.
  • Supported creation of detailed, technical financial models to value potential acquisition targets.
  • Frequently inspected production area to verify proper equipment operation.
  • Gathered, organized and input information into digital database.
  • Promoted critical thinking by designing challenging assignments that required students to analyze and synthesize information.

Consent Decree Specialist QA Lead for Laboratory Controls

Genzyme Corp.
03.2012 - 02.2013
  • Site under Consent Decree. Part of the site subject matter experts and the Global Consent Decree teams are responsible to build compliant quality systems for areas of responsibility and ensure that the deliverables and milestones are delivered on time. In addition, Support the development and implementation of assigned quality system elements (QSE) and other consent decree activities as directed by the CDMO office.
  • Followed all company policies and procedures to deliver quality work.
  • Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
  • Collaborated with cross-functional teams to achieve project goals on time and within budget.
  • Implemented new training programs for staff, leading to higher employee retention rates and better overall performance.
  • Championed the adoption of new software tools that streamlined workflows across multiple departments.
  • Enhanced customer satisfaction with timely and accurate issue resolution.
  • Coordinated with IT department to upgrade cybersecurity measures, safeguarding company data.
  • Developed training materials to enhance staff proficiency and productivity.
  • Improved team collaboration by initiating regular strategy meetings.
  • Increased efficiency by automating routine tasks with software solutions.
  • Initiated sustainability program, reducing company's environmental impact.
  • Negotiated with suppliers to reduce material costs, improving profit margins.
  • Restructured customer service process, ensuring quicker response times.
  • Analyzed sales data to identify trends and adjust marketing strategies accordingly.
  • Led cross-functional team to launch new product, exceeding initial sales forecasts.
  • Implemented customer feedback system to inform product development.
  • Conducted comprehensive competitor analysis to inform strategic decisions.
  • Assisted in developing strategic plan that aligned with long-term company goals.
  • Optimized inventory management, minimizing waste and reducing costs.
  • Designed employee recognition program that improved morale and reduced turnover.
  • Facilitated workshops for professional development of junior staff members.
  • Conducted in-depth market research for identifying new business opportunities.
  • Boosted company's online presence by developing comprehensive digital marketing strategy.
  • Led quality assurance efforts, maintaining high standards for all products and services.
  • Streamlined project delivery processes, reducing completion times significantly.
  • Gathered, organized and input information into digital database.
  • Optimized customer experience by delivering superior services and effectively troubleshooting issues.
  • Collected, arranged, and input information into database system.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Generated reports detailing findings and recommendations.
  • Helped meet changing demands by recommending improvements to business systems or procedures.
  • Maintained database systems to track and analyze operational data.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
  • Developed effective improvement plans in alignment with goals and specifications.
  • Created and managed project plans, timelines and budgets.
  • Devised and implemented processes and procedures to streamline operations.
  • Evaluated staff performance and provided coaching to address inefficiencies.
  • Frequently inspected production area to verify proper equipment operation.
  • Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
  • Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
  • Observed packing operations to verify conformance to specifications.
  • Supported creation of detailed, technical financial models to value potential acquisition targets.
  • Mentored junior team members, fostering growth and enhancing team performance.
  • Standardized bug reporting methods for better communication between QA and development teams.
  • Implemented automation tools, increasing testing accuracy and reducing manual effort.
  • Managed multiple projects simultaneously, ensuring timely delivery of high-quality products.
  • Championed the adoption of best practices in QA methodologies throughout the organization.
  • Reduced defect leakage by effectively conducting regression testing after each release cycle.
  • Facilitated seamless integration of new team members into ongoing projects through comprehensive training programs and documentation support.
  • Collaborated with development teams to resolve issues and implement improvements, elevating overall product quality.
  • Conducted root cause analysis on recurring defects, implementing preventative measures to reduce future occurrences.
  • Optimized test coverage by defining clear test objectives and prioritizing scenarios based on risk assessment.
  • Increased team productivity by continuously reviewing existing workflows and recommending enhancements.
  • Enhanced software quality by developing comprehensive test strategies and plans.
  • Led cross-functional teams to ensure seamless collaboration in achieving project goals.
  • Developed reusable test scripts for efficient execution across multiple platforms and environments.
  • Streamlined QA processes for improved efficiency, reducing project completion time.
  • Evaluated emerging trends and technologies in software testing to maintain a competitive edge in the market.
  • Established key performance indicators to measure the success of testing efforts and drive continuous improvement.
  • Ensured compliance with industry standards such as ISO 9000 or CMMI through diligent auditing of QA processes.
  • Updated quality control standards, methods, and procedures to meet compliance requirements.
  • Increased customer satisfaction through adherence to quality standards and customer requirements.
  • Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
  • Evaluated quality problems and performed assessments to identify and resolve issues.
  • Developed and deployed production control plans and created work instructions and procedures.
  • Improved quality processes for increased efficiency and effectiveness.
  • Inspected inbound and outbound products for compliance with established industry standards, company policies, and procedures.
  • Mentored and encouraged employees to strive for excellence while fostering professional growth.
  • Devised specifications for processes.
  • Sorted product and provided expertise on non-conforming product requirements.
  • Wrote and implemented new rework procedures to standardize processes and streamline workflow.
  • Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
  • Managed and archived quality documentation and participated in internal and external quality audits.
  • Provided observations, took measurements, and performed tests at various stages according to quality control plan.
  • Liaised with HR manager to organize and perform quality standard training for new and existing staff.
  • Calibrated instruments and scales in production area and quality lab.
  • Operated under Agile and Scrum frameworks to complete releases and well-organized sprints.
  • Monitored resolution of bugs, tested fixes, and helped developers tackle ongoing problems by providing QA perspective.
  • Tested functional and compatibility of new programs or updates in comparison to existing applications.
  • Documented testing procedures for developers and future testing use.
  • Gathered data on integration issues and vulnerabilities, reported findings and recommended improvements.
  • Built automated test scripts to handle repetitive software testing work.
  • Evaluated function, performance and design compliance of every product against design standards and customer needs.
  • Completed pre-implementation testing for new system modifications to assess potential impacts.
  • Developed and maintained defect databases for known issues.
  • Authored and maintained well-organized, efficient and successful manual test cases for entire team.
  • Kept scripts and test cases updated with current requirements.
  • Advised developers on problems with databases, performance and other issues.
  • Incorporated delivery requirements into planning of testing schedules.
  • Completed in-depth usability testing on Windows, Android and iOS mobile devices.
  • Recommended changes and corrections to developers for optimal software performance and usability.

Regulatory Affairs Labeling Manager

Pfizer Pharmaceuticals USA
03.2009 - 11.2012
  • Supports the product Regulatory Lead/Strategist in the management of labeling text through the processes and systems designed to support the optimal delivery and ultimate approval of Pfizer product labeling and was responsible for managing the logistical aspects of the Labeling Sub-Team. Established Portfolio Labeling Lead (PLL) Regulatory Lead/Strategist, she was responsible for delivering “submission ready” product labels in applicable formats to support the submission and approval of Pfizer products. Other activities and responsibilities are included;
  • Managed and motivated employees to be productive and engaged in work.
  • Accomplished multiple tasks within established timeframes.
  • Maintained professional, organized, and safe environment for employees and patrons.
  • Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
  • Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
  • Maximized performance by monitoring daily activities and mentoring team members.
  • Cross-trained existing employees to maximize team agility and performance.
  • Controlled costs to keep business operating within budget and increase profits.
  • Developed and maintained relationships with customers and suppliers through account development.
  • Developed a strong company culture focused on employee engagement, collaboration, and continuous learning opportunities.
  • Improved safety procedures to create safe working conditions for workers.
  • Built high-performing teams through effective recruitment, onboarding, and talent development initiatives.
  • Managed budgets effectively, ensuring optimal financial performance while investing in necessary resources for business growth.
  • Improved marketing to attract new customers and promote business.
  • Reduced operational costs through comprehensive process improvement initiatives and resource management.
  • Mentored junior team members for career advancement, fostering a pipeline of future leaders within the organization.
  • Streamlined workflows by identifying bottlenecks in existing systems and implementing appropriate solutions.
  • Oversaw inventory management, optimizing stock levels, and reducing waste.
  • Developed comprehensive risk management plan, minimizing potential disruptions to business operations.
  • Organized professional development programs for staff, leading to improved performance and skill sets.
  • Streamlined project delivery processes, significantly reducing time to market for new product launches.
  • Spearheaded transition to remote work during global health crisis, ensuring business continuity and employee safety.
  • Facilitated team brainstorming sessions that led to innovative solutions for long-standing operational challenges.
  • Increased market share with strategic business development efforts, expanding into untapped markets.
  • Coordinated with IT department to upgrade technology infrastructure, enhancing operational efficiency and data security.
  • Improved customer satisfaction scores by overhauling customer service protocols and training staff in customer engagement techniques.
  • Negotiated favorable terms with suppliers, cutting operational costs while maintaining quality of service.
  • Managed budget allocations to prioritize spending on high-impact projects, optimizing resource utilization.
  • Fostered partnerships with industry leaders, enhancing company's reputation and creating new business opportunities.
  • Led cross-functional teams to achieve project goals, fostering collaboration and innovation.
  • Conducted market research to identify customer needs and adjusted product offerings accordingly, increasing customer satisfaction.
  • Enhanced product quality by instituting rigorous quality control procedures, resulting in fewer customer complaints.
  • Achieved significant cost savings by renegotiating contracts with key vendors, without compromising service quality.
  • Implemented customer feedback mechanisms to gather insights, using this information to guide strategic planning and decision-making.
  • Enhanced team productivity by implementing agile methodologies, leading to more efficient project completion.
  • Developed and executed marketing strategies that effectively communicated brand values, increasing brand recognition.
  • Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
  • Established team priorities, maintained schedules and monitored performance.
  • Evaluated employee performance and conveyed constructive feedback to improve skills.
  • Maintained professional demeanor by staying calm when addressing unhappy or angry customers.
  • Opened and closed location and monitored shift changes to uphold successful operations strategies and maximize business success.
  • Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
  • Defined clear targets and objectives and communicated to other team members.
  • Improved staffing during busy periods by creating employee schedules and monitoring call-outs.
  • Used industry expertise, customer service skills and analytical nature to resolve customer concerns and promote loyalty.
  • Established performance goals for employees and provided feedback on methods for reaching those milestones.
  • Assisted in organizing and overseeing assignments to drive operational excellence.
  • Successfully managed budgets and allocated resources to maximize productivity and profitability.
  • Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.
  • Trained personnel in equipment maintenance and enforced participation in exercises focused on developing key skills.
  • Developed detailed plans based on broad guidance and direction.
  • Set aggressive targets for employees to drive company success and strengthen motivation.
  • Identified and communicated customer needs to supply chain capacity and quality teams.
  • Reduced waste and pursued revenue development strategies to keep department aligned with sales and profit targets.
  • Controlled resources and assets for department activities to comply with industry standards and government regulations.
  • Launched quality assurance practices for each phase of development
  • Streamlined and monitored quality programs to alleviate overdue compliance activities.
  • Managed senior-level personnel working in marketing and sales capacities.
  • Leveraged data and analytics to make informed decisions and drive business improvements.
  • Planned, created, tested and deployed system life cycle methodology to produce high quality systems to meet and exceed customer expectations.

Regulatory Affairs Specialist Labeling/Project Manager

St Jude Medical Berlin, NJ
01.2009 - 12.2009
  • Reported to the Director of Regulatory Affairs. Responsible for providing leadership in four key operational areas of the Regulatory Affairs-Labeling department. Organization, authority, and review of the Company Core DataSheets (CCDS) and optimization of product labeling, meeting version control and archive. Planning and coordination of workflow associated with the review of Core Datasheets by the company’s Core Labeling Working Group and Core Labeling Review Committee. Establishment of systems and processes to track the implementation of revisions to CCDS into country labeling. Implemented the Change Order program to track and review each change order to determine if the Technical File needs to be updated accordingly.
  • Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
    • Supports the product release process by reviewing and approving requests for product release.
    • Interfaces directly with U.S. Food and Drug Administration (FDA) and other regulatory agencies.
    • Conducts reviews of product and manufacturing changes for compliance with applicable regulations. Review protocols and reports to support regulatory submissions. Creates, reviews and approves product change orders.
    • Communicates with and maintains productive, constructive relationships with external customers as required – US FDA, Health Canada, in-country regulatory representatives, and notified- bodies.
    • Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Led product teams of 16 for regulatory product compliance on company's
  • Performed and documented quality control checks to maintain compliance with company initiatives.
  • Recommended improvements to processes.
  • Conducted thorough audits to identify areas of improvement and implement corrective actions for regulatory compliance.
  • Maintained detailed records of all regulatory activities, enabling quick access during inspections or audits.
  • Facilitated productive communication between company management and regulatory agencies, fostering positive relationships.
  • Prepared and submitted regulatory file applications and supporting documentation.
  • Participated in negotiations with regulators during inspections or audits, advocating on behalf of the company''s best interests while respecting agency expectations.
  • Assisted in preparing high-quality submissions for FDA approval, leading to faster market entry for products.
  • Provided training to colleagues on regulatory requirements, resulting in increased awareness and overall compliance within the organization.
  • Prioritized project-related tasks to efficiently complete essential tasks.
  • Analyzed competitor data, staying informed about industry developments that could impact current or future products.
  • Completed and reported on product impact assessments.
  • Received, researched, and resolved consumer inquiries.
  • Maintained and archived regulatory paperwork.
  • Implemented regulatory guidance procedures for product label design.
  • Assisted in preparation of high-quality submissions for FDA approval, leading to faster market entry for products.
  • Received, researched and resolved consumer inquiries.
  • Completed and reported on product impact assessments.
  • Ensured consistency in product labeling by reviewing and approving label designs and promotional materials.
  • Monitored post-market surveillance activities, identifying trends and addressing any potential safety concerns promptly.
  • Prepared and maintained document inventory for core dossier preparation.
  • Streamlined internal processes for timely submission of regulatory documentation to authorities.
  • Enhanced regulatory compliance by developing and implementing robust policies and procedures.
  • Contributed to successful product launches by coordinating with various departments to ensure all necessary approvals were obtained beforehand.
  • Stayed updated on changing regulations by attending industry conferences, maintaining professional expertise in the field.
  • Evaluated new business opportunities from a regulatory perspective, providing valuable insight into potential challenges or benefits.
  • Worked with governance committees to make and evaluate plans.
  • Advised executive management on the strategic direction of regulatory activities, incorporating both short-term and long-term goals for the company.
  • Supported product development by offering guidance on applicable regulations throughout the process, ensuring adherence at every stage.
  • Collaborated with cross-functional teams to develop risk mitigation strategies, reducing potential non-compliance issues.
  • Established strong relationships with global regulatory counterparts, facilitating efficient information exchange and collaboration.
  • Developed or tracked quality metrics.

Regulatory Affairs/Quality Control / R&D Labeling Director

Bio-Pharm, Inc.
05.2007 - 12.2008
  • Site under Warning Letter. Served as the Regulatory Affairs & Quality Control Director responsible for the compilation, submission, and maintenance of various clinical and nonclinical regulatory documents, including three ANDA submissions. Ensured that the elements, quality, accuracy, and format of regulatory submissions complied with applicable laws, regulations, and corporate standards. These efforts allowed for meeting compliance commitments on time, and within budget, with no training-related warning letter/observations.
  • Site Under Warning Letter
  • Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
  • Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
  • Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
  • Cultivated a positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.
  • Managed budgets effectively to ensure optimal use of resources while maintaining financial stability.
  • Strengthened internal controls by reviewing existing policies and procedures, ensuring compliance with regulatory requirements.
  • Facilitated cross-functional collaboration for improved decision-making processes within the organization.
  • Improved project efficiency with strategic planning, resource allocation, and time management practices.
  • Implemented innovative solutions to solve complex problems, resulting in increased productivity and streamlined operations.
  • Proactively identified potential risks and implemented mitigation strategies to minimize negative impacts on projects or business operations.
  • Leveraged professional networks and industry knowledge to strengthen client relationships.
  • Spearheaded innovative approaches to resource allocation and strategic planning.
  • Negotiated favorable contracts with vendors for reduced costs and improved service quality.
  • Increased company revenue by streamlining processes and implementing cost-saving measures.
  • Boosted client satisfaction rates through exceptional relationship management and prompt resolution of issues.
  • Secured key partnerships that contributed to the company''s overall growth strategy and market reach.
  • Evaluated employee performance objectively using established metrics, leading to fair compensation adjustments based on meritocracy principles.
  • Leveraged data analytics insights for informed decision-making in critical areas such as sales forecasting, budgeting, or personnel management.
  • Spearheaded successful product launches that resulted in increased brand visibility and customer acquisition.
  • Elevated company profile in industry by spearheading comprehensive rebranding initiative.
  • Improved team morale and productivity by implementing comprehensive professional development program.
  • Enhanced data-driven decision-making by implementing advanced analytics and reporting tools.
  • Streamlined project delivery mechanisms, significantly reducing time to market for new initiatives.
  • Achieved remarkable turnaround of underperforming divisions through strategic leadership and restructuring.
  • Enhanced stakeholder satisfaction with timely and transparent communication strategies.
  • Optimized inventory management to minimize costs and ensure product availability.
  • Boosted operational efficiency by optimizing supply chain processes.
  • Strengthened financial health with rigorous cost control measures and revenue enhancement strategies.
  • Pioneered adoption of sustainable practices, leading to industry recognition and awards.
  • Navigated company through periods of significant change, maintaining focus on long-term strategic goals.
  • Revolutionized customer service protocols, significantly improving customer satisfaction ratings.
  • Cultivated high-performance executive team, selecting and mentoring candidates for key leadership roles.
  • Fostered culture of innovation, encouraging development of cutting-edge solutions.
  • Reinforced company's competitive position by securing intellectual property rights and fostering innovation.
  • Expanded into new markets, conducting thorough market analysis and establishing key local partnerships.
  • Secured lucrative partnerships to expand market reach, negotiating favorable terms.
  • Drove significant market share growth with launch of innovative product lines.
  • Led cross-functional teams to exceed benchmarks for SLA delivery, staying on top of challenging schedules with multiple competing timelines.
  • Transformed organizational culture to embrace continuous improvement, leading by example and mentoring teams.
  • Raised property accuracy and accountability by creating new automated tracking method.
  • Supervised creation of exciting merchandise displays to catch attention of store customers.
  • Monitored daily cash discrepancies, inventory shrinkage and drive-off.
  • Updated and resolved incidents and managed accessorial charges objectively while maximizing profit.
  • Reduced operational risks while organizing data to forecast performance trends.
  • Launched staff engagement, gender diversity and cultural programs in addition to robust reporting tool that increased operational quality.
  • Reduced financial inconsistencies while assessing and verifying billing invoices and expense reports.
  • Implemented innovative programs to increase employee loyalty and reduce turnover.
  • Reduced budgetary expenditures by effectively negotiating contracts for more advantageous terms.
  • Identified and qualified customer needs and negotiated and closed profitable projects with high success rate.
  • Managed purchasing, sales, marketing and customer account operations efficiently.
  • Tracked trends and suggested enhancements to both challenge and refine company's product offerings.
  • Scheduled employees for shifts, taking into account customer traffic and employee strengths.
  • Reported issues to higher management with great detail.
  • Negotiated price and service with customers and vendors to decrease expenses and increase profit.
  • Tracked employee attendance and punctuality, addressing repeat problems quickly to prevent long-term habits.
  • Handled problematic customers and clients to assist lower-level employees and maintain excellent customer service.
  • Implemented business strategies, increasing revenue, and effectively targeting new markets.
  • Observed each employee's individual strengths and initiated mentoring program to improve areas of weakness.
  • Cultivated and strengthened lasting client relationships using strong issue resolution and dynamic communication skills.
  • Interacted well with customers to build connections and nurture relationships.
  • Recruited, hired, and trained initial personnel, working to establish key internal functions and outline scope of positions for new organization.
  • Assisted in recruiting, hiring and training of team members.
  • Trained and guided team members to maintain high productivity and performance metrics.

Project Lead/CSV – Consultant

Johnson & Johnson
04.2006 - 09.2007
  • Responsible for the management, review, development, and execution of the computer system Validation and SDLC Projects including Project Plan and streamlines, the development of CSV documents for new systems and system updates, such as Validation Plan, System Configuration Specifications, Functional & User Requirement Specification, Traceability Metrics, IQ/OQ/PQ, Security Metric, System Testing, User Acceptance Testing and Validation Final Report. Wrote/edited all types of CSV documentation and SOPs. Facilitated the Computer System Validation Risk Assessment to identify governing regulations and validation deliverables.
  • Streamlined project management processes by implementing Agile methodologies and improving team communication.
  • Optimized resource utilization by accurately forecasting project needs and allocating resources accordingly throughout the project lifecycle.
  • Improved overall team performance by conducting regular performance evaluations and providing constructive feedback to facilitate professional growth.
  • Collaborated with cross-functional teams to ensure seamless integration of various project components.
  • Facilitated clear communication between internal departments, ensuring all parties remained aligned on goals throughout the duration of each project.
  • Partnered with project team members to identify and quickly address problems.
  • Ensured timely delivery of critical deliverables by closely monitoring progress against milestones and adjusting plans as necessary.
  • Developed comprehensive project plans that clearly outlined objectives, timelines, budgets, risks, and success metrics for all stakeholders.
  • Enhanced client satisfaction by consistently delivering high-quality projects within budget and on schedule.
  • Saved costs on multiple projects by identifying opportunities for process improvement and implementing cost-effective solutions.
  • Implemented best practices in documentation management systems that improved efficiency, accessibility, and security of project-related information.
  • Established clear performance metrics, enabling more effective tracking of project progress.
  • Negotiated with vendors to secure resources, optimizing budget allocation.
  • Enhanced team collaboration by implementing agile project management methodologies.
  • Initiated quality assurance practices that resulted in higher client satisfaction rates.
  • Oversaw development and execution of project timelines, significantly reducing delays.
  • Streamlined communication channels between departments, facilitating smoother project execution.
  • Improved project outcomes with rigorous risk management processes.
  • Fostered culture of continuous improvement, leading to more efficient project workflows.
  • Conducted post-project evaluations to identify lessons learned and opportunities for process enhancement.
  • Leveraged project management software to enhance team communication and document sharing.
  • Adapted project plans in response to changing requirements, minimizing disruptions to project timelines.
  • Ensured compliance with industry standards and regulations, maintaining project integrity and client trust.
  • Encouraged innovation among team members, leading to development of more effective project strategies.
  • Balanced multiple projects simultaneously, maintaining focus on priorities and deadlines.
  • Implemented technology solutions to automate repetitive tasks, boosting team productivity.
  • Led cross-functional teams to streamline project delivery, ensuring alignment with client expectations.
  • Coordinated with stakeholders to define project scopes, aligning objectives with business goals.
  • Mentored junior project managers, enhancing their leadership skills and project management capabilities.
  • Developed comprehensive project documentation, ensuring clarity and accessibility for all team members.
  • Facilitated workshops for stakeholder engagement, ensuring buy-in and support for project initiatives.
  • Maintained open communication by presenting regular updates on project status to customers.
  • Tracked project and team member performance closely to quickly intervene in mistakes or delays.
  • Monitored project progress, identified risks and took corrective action as needed.
  • Analyzed project performance data to identify areas of improvement.
  • Developed and implemented project plans and budgets to ensure successful execution.
  • Facilitated workshops to collect project requirements and user feedback.
  • Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
  • Sourced, vetted and managed vendors needed to accomplish project goals.
  • Recruited and oversaw personnel to achieve performance and quality targets.
  • Reported regularly to managers on project budget, progress, and technical problems.
  • Verified quality of deliverables and conformance to specifications before submitting to clients.
  • Increased efficiency in documentation management by creating well-organized repositories for all CSV-related materials.
  • Reduced validation errors by conducting thorough risk assessments and gap analyses.
  • Streamlined project timelines by effectively managing CSV tasks and resources.
  • Provided expert guidance during system upgrades, minimizing downtime and ensuring smooth transitions for users.
  • Optimized system functionality through careful evaluation of user requirements and design specifications.
  • Demonstrated exceptional problem-solving skills when faced with complex issues related to computer system validation efforts.
  • Collaborated closely with clients to develop customized training materials tailored to their specific needs and expectations for CSV projects.
  • Delivered high-quality deliverables consistently while adhering to strict deadlines, resulting in increased client satisfaction levels.
  • Developed comprehensive test plans to ensure successful system implementation and user acceptance.
  • Evaluated vendor solutions critically, selecting appropriate tools that met organizational needs while remaining compliant with regulatory standards.
  • Actively participated in project review meetings, providing valuable input on progress updates and potential roadblocks encountered during the course of the work.
  • Facilitated cross-functional collaboration, leading to more effective communication among team members and stakeholders.
  • Improved compliance with industry regulations through diligent adherence to CSV guidelines and best practices.
  • Established reliable protocols for change control management, ensuring proper tracking and documentation of system modifications.
  • Cultivated strong rapport with clients by maintaining open lines of communication, fostering trust and confidence in the consultant''s ability to deliver on project requirements.
  • Supported business process improvement initiatives by analyzing current workflows and recommending optimizations based on CSV principles.
  • Maintained a strong knowledge base of industry trends, sharing insights with colleagues to enhance overall team performance.
  • Mentored junior consultants, contributing to their professional growth and development within the organization.
  • Monitored and reported on test results and performance data to identify areas of opportunity for improvement.
  • Enhanced data quality by implementing efficient validation processes for CSV projects.
  • Ensured data integrity by conducting regular audits on validated systems, addressing discrepancies promptly.
  • Collaborated with cross-functional teams for identification and resolution of validation issues.
  • Developed validation master plans, process flow diagrams and standard operating procedures.
  • Demonstrated new product features and functionality to project stakeholders.
  • Produced and maintained technical documentation for project reference.
  • Met tight deadlines to satisfy client demands and project timelines.
  • Proposed development and testing improvements to positively impact usability, function and performance.
  • Worked with stakeholders and team members on quality assurance efforts for hardware components.
  • Trained and guided onsite and offshore team members in quality assurance standards, policies and procedures.
  • Drove corrective actions to accomplish project closure and recurrence control.
  • Mentored junior team members, fostering professional growth and increasing overall team efficiency.
  • Established strong relationships with clients, leading to repeat business and positive referrals for the company.

Sr. Project Manager - Laboratory & Computer System

Par Pharmaceutical
08.2004 - 12.2006
  • Managed multiple projects in support of Computer System Validation, business analysis, Quality Assurance & compliance, and decision support. Orchestrated all aspects of a project life cycle, including project planning, scope definition, requirements gathering, design, change control, user testing, implementation, customer relationships, training, and team leadership. Projects included the following: TrackWise, Data Servers, LabWare LIMS System, Empower, Maximo 4.1.1, Documentum, and Blue Mountain Calibration Manager System Upgrade. In addition, responsible for the new and existing Laboratory Instruments and Computer System validation projects including IT Administrator activities for QC and R&D Laboratories. Activities included: reviewing and approving Validation protocols for both laboratory instruments hardware and software such as HPLC, GC, Dissolution apparatus, UV/Vis, ChemStore, ChemStation, Empower, etc.
  • Maintained schedules to meet key milestones at every project phase.
  • Directed changes to project scope and cost and implemented appropriate change management processes to keep project on track.
  • Presented regular status reports to executive leadership, providing insights into progress made toward achieving key milestones.
  • Mentored junior project managers and team members to enhance their skills and career growth.
  • Established effective communication channels with stakeholders to ensure transparency and alignment of expectations.
  • Adapted quickly to unexpected challenges or obstacles encountered during project execution, devising creative solutions without compromising objectives.
  • Provided outstanding service to clients through effective communication and prompt issue resolution to facilitate future business opportunities.
  • Communicated project plans and progress to key stakeholders and project contributors.
  • Negotiated contracts with vendors and suppliers, securing favorable terms for the organization''s benefit.
  • Developed comprehensive project plans, identifying risks and mitigation strategies for timely completion.
  • Developed and maintained project budgets to control costs and meet organizational and project goals.
  • Led cross-functional teams for successful project delivery within scope, schedule, and budget constraints.
  • Streamlined project management processes by implementing agile methodologies, resulting in improved efficiency and reduced costs.
  • Monitored project progress, identified risks and implemented corrective measures to acquire success.
  • Ensured compliance with industry regulations by staying current on changes in legislation or guidelines relevant to projects'' scopes.
  • Established and managed change management processes to fulfill successful project transitions.
  • Partnered with project team members to identify and quickly address problems.
  • Implemented change management processes to accommodate evolving project requirements while minimizing disruptions.
  • Managed budgets exceeding $1 million while effectively controlling costs through diligent financial oversight.
  • Coordinated cross-functional teams to determine timely delivery and compliance of project requirements.
  • Evaluated vendor proposals, selecting those that provided the best value for cost, quality, and timeliness.
  • Optimized resource allocation by closely monitoring project progress and adjusting team assignments as needed.
  • Conducted post-project evaluations to identify areas of improvement and implement corrective actions for future endeavors.
  • Championed innovative approaches when faced with complex problems or opportunities requiring non-traditional thinking.
  • Developed and led multi-disciplinary team to redefine problems and reach solutions based on different perspectives.
  • Delivered high-quality results by fostering a culture of accountability among team members and setting clear performance expectations.
  • Crafted and maintained project plans and schedules to meet organizational objectives.
  • Nurtured strong working relationships with internal and external stakeholders, building trust and credibility that facilitated smooth collaboration on shared goals.
  • Spearheaded process improvement initiatives that resulted in increased productivity and streamlined workflows across departments.
  • Oversaw large portfolio of projects to support teams, report progress, and influence positive outcomes for key stakeholders.
  • Monitored contracts and service level agreements to identify potential risks and implement mitigation actions to protect development process from unforeseen delays and costs.
  • Collaborated with business analysts to gather requirements, ensuring projects met client needs and expectations.
  • Achieved substantial cost savings by renegotiating contracts with key suppliers and optimizing resource allocation across projects.
  • Enhanced team collaboration and efficiency with introduction of cutting-edge project management software.
  • Drove organizational change by leading implementation of strategic initiatives, achieving significant improvements in business processes and efficiency.
  • Pioneered use of data analytics in project management, enabling more informed decision-making and strategic planning.
  • Developed comprehensive risk management plans to minimize project delays and budget overruns, safeguarding project outcomes.
  • Conducted detailed post-project evaluations to identify key learnings and areas for improvement, fostering culture of continuous improvement.
  • Coordinated with regulatory bodies to ensure all projects complied with industry standards and regulations, mitigating legal and financial risks.
  • Spearheaded adoption of sustainable practices in project execution, reducing environmental impact and promoting corporate social responsibility.
  • Championed corporate values and ethics in all project activities, setting strong example for team members and reinforcing company's reputation for integrity.
  • Facilitated knowledge sharing and skill development workshops for project team members, enhancing team capabilities and project outcomes.
  • Cultivated culture of innovation within project teams, encouraging exploration of new ideas and approaches to problem-solving.
  • Streamlined project delivery timelines by implementing agile methodologies, significantly enhancing team productivity and client satisfaction.
  • Successfully recovered projects at risk of failure, implementing turnaround strategies that restored client confidence and secured project objectives.
  • Established and maintained strong relationships with external stakeholders, including clients and partners, ensuring smooth project execution and new business opportunities.
  • Improved stakeholder communication by establishing regular update meetings and clear reporting channels, resulting in increased trust and partnership.
  • Led cross-functional teams in successful completion of multimillion-dollar projects, ensuring they met all scope, time, and budget requirements.
  • Negotiated conflicts within project teams to ensure smooth project execution and maintain high morale.
  • Optimized team performance and project outcomes by setting clear goals and expectations, coupled with regular performance reviews.
  • Oversaw development and implementation of training programs for junior project managers, building pipeline of future leaders.
  • Enhanced client satisfaction and loyalty by delivering projects that consistently exceeded expectations in terms of quality, timeline, and budget.
  • Tracked project and team member performance closely to quickly intervene in mistakes or delays.
  • Maintained open communication by presenting regular updates on project status to customers.
  • Developed and implemented project plans and budgets to ensure successful execution.
  • Monitored project progress, identified risks and took corrective action as needed.
  • Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
  • Reported regularly to managers on project budget, progress, and technical problems.
  • Analyzed project performance data to identify areas of improvement.
  • Sourced, vetted and managed vendors needed to accomplish project goals.
  • Verified quality of deliverables and conformance to specifications before submitting to clients.
  • Recruited and oversaw personnel to achieve performance and quality targets.
  • Facilitated workshops to collect project requirements and user feedback.

Project Manager/ Computer System Validation Specialist

Sharp Corporation
01.2006 - 05.2006
  • Responsible for the development and execution of the computer system Life Cycle Protocols for the CAPA’s (Track Wise) System, including the Administrator module, Integration Manager, and data migration tool. Supported the preparation of the process and packaging equipment validation documents. Responsible for the development of a training program for the Quality Assurance personnel, which included the preparation of a training matrix and new SOPs according to individual functions.
  • Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
  • Planned, designed, and scheduled phases for large projects.
  • Met project deadlines without sacrificing build quality or workplace safety.
  • Established effective communication among team members for enhanced collaboration and successful project completion.
  • Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
  • Delivered exceptional customer satisfaction by proactively addressing client concerns and meeting or exceeding expectations throughout the engagement process.
  • Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
  • Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team''s ability to deliver results.
  • Identified plans and resources required to meet project goals and objectives.
  • Coordinated with cross-functional teams to resolve project issues and mitigate risks.
  • Monitored project performance to identify areas of improvement and make adjustments.
  • Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle.
  • Provided detailed project status updates to stakeholders and executive management.
  • Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
  • Managed projects from procurement to commission.
  • Provided detailed technical and operational direction in project challenges, consistently meeting deliverables according to deadlines.
  • Prepared detailed reports on project status for stakeholders, ensuring transparency and alignment with objectives.
  • Coordinated material procurement and required services for projects within budget requirements.
  • Negotiated contracts with vendors and suppliers, securing quality materials at competitive prices for efficient use of resources.
  • Negotiated and managed third-party contracts related to project deliverables.
  • Created accurate budgets based on resource requirements, allowing for optimal allocation of funds across all aspects of the projects.
  • Effectively managed scope creep by establishing clear boundaries on requested changes while keeping projects aligned with original objectives and budgets.
  • Implemented continuous improvement initiatives to optimize project outcomes while maintaining costeffectiveness.
  • Mentored junior team members in project management best practices to enhance their skills and contribute to better overall performance.
  • Enhanced overall project success by conducting thorough post-project evaluations and incorporating lessons learned into future efforts.
  • Fostered a culture of innovation and creativity within the project team, leading to improved problem-solving capabilities and enhanced outcomes.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Enhanced project delivery times by streamlining communication channels between development and operations teams.
  • Completed projects within tight deadlines, coordinating team efforts and prioritizing tasks effectively.
  • Facilitated smoother project transitions, ensuring thorough documentation and effective handovers.
  • Streamlined procurement process for project materials, reducing wait times and avoiding potential delays.
  • Achieved significant improvements in project quality by establishing rigorous quality control processes.
  • Enhanced team performance with targeted training programs, addressing skill gaps and promoting professional development.
  • Improved client relationships, consistently meeting or exceeding project expectations and maintaining open lines of communication.
  • Developed comprehensive risk management plans, minimizing project delays and unexpected challenges.
  • Reduced project costs, negotiating contracts with suppliers and optimizing resource allocation.
  • Promoted innovation within project teams, encouraging exploration of new tools and methodologies to enhance project outcomes.
  • Ensured projects aligned with strategic objectives, working closely with senior management to refine project goals.
  • Optimized project schedules, identifying critical path tasks and reallocating resources to maintain momentum.
  • Led cross-functional teams to successful project completions, improving team cohesion and productivity with effective leadership strategies.
  • Oversaw implementation of new project management software, facilitating more efficient workflow and better project tracking.
  • Enhanced project visibility, implementing dashboard and reporting tools for real-time progress monitoring.
  • Streamlined project initiation processes, enabling quicker transition from planning to execution.
  • Fostered culture of continuous improvement, conducting post-project reviews to identify lessons learned and best practices.
  • Maintained compliance with industry standards and regulations, conducting regular audits and updates to project practices.
  • Improved stakeholder satisfaction with detailed project updates and proactive issue resolution.
  • Achieved high levels of team engagement and morale by promoting collaborative and inclusive work environment.
  • Monitored project progress, identified risks and took corrective action as needed.
  • Tracked project and team member performance closely to quickly intervene in mistakes or delays.
  • Maintained open communication by presenting regular updates on project status to customers.
  • Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
  • Reported regularly to managers on project budget, progress, and technical problems.
  • Developed and implemented project plans and budgets to ensure successful execution.
  • Sourced, vetted and managed vendors needed to accomplish project goals.
  • Analyzed project performance data to identify areas of improvement.
  • Recruited and oversaw personnel to achieve performance and quality targets.
  • Verified quality of deliverables and conformance to specifications before submitting to clients.
  • Facilitated workshops to collect project requirements and user feedback.
  • Supported internal audits by providing necessary documentation related to validation efforts, ensuring compliance with established standards.
  • Reduced process variability with the development of robust validation protocols and procedures.
  • Identified areas for improvement in existing validation systems, recommending changes that led to increased efficiency.
  • Led the training of junior team members on validation principles and techniques, fostering a culture of continuous learning within the organization.
  • Prepared detailed qualification documents including IQ/OQ/PQ protocols and reports for equipment and systems within regulated environments.
  • Fostered a culture of continuous improvement by actively seeking feedback from team members, implementing process enhancements based on lessons learned.
  • Reviewed vendor-provided documentation critically assessing their capabilities in meeting project expectations before engaging in collaborations or outsourcing activities.
  • Performed gap analyses between existing practices and required standards leading to the development of targeted action plans for compliance achievement.
  • Managed change control initiatives ensuring that all system modifications underwent proper revalidation before implementation into production environments.
  • Assisted in the preparation of regulatory submissions by providing validation-related documentation, contributing to successful approval outcomes.
  • Ensured adherence to industry best practices by staying current on relevant guidelines such as FDA 21 CFR Part 11 and EU GMP Annex 15.
  • Conducted thorough root cause analyses to address deviations during validation activities, implementing corrective actions as needed.
  • Developed comprehensive validation plans, outlining objectives, timelines, and resource requirements for successful project execution.
  • Optimized resource allocation by prioritizing critical validations based on business needs and regulatory requirements.
  • Collaborated with cross-functional teams to ensure timely completion of validation projects, meeting regulatory requirements.
  • Maintained excellent communication with stakeholders throughout validation projects, keeping them informed about progress and potential challenges.
  • Enhanced product quality through rigorous testing and data analysis of manufacturing processes.
  • Participated in external audits conducted by regulatory authorities demonstrating a high level of expertise and preparedness during inspections.
  • Improved validation processes by implementing risk-based approaches and streamlining documentation.
  • Trained and assisted staff in validation techniques, methods and testing processes.
  • Documented entire validation process, noting changes or alterations completed.
  • Identified causes of equipment failures and made suggestions for issue resolution.
  • Participated in system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines.
  • Explained highly complex information in terms easily understood by non-technical personnel.
  • Analyzed pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
  • Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
  • Monitored and reported on test results and performance data to identify areas of opportunity for improvement.
  • Collaborated with cross-functional teams for identification and resolution of validation issues.
  • Developed validation master plans, process flow diagrams and standard operating procedures.
  • Demonstrated new product features and functionality to project stakeholders.
  • Produced and maintained technical documentation for project reference.
  • Met tight deadlines to satisfy client demands and project timelines.
  • Proposed development and testing improvements to positively impact usability, function and performance.
  • Worked with stakeholders and team members on quality assurance efforts for hardware components.
  • Trained and guided onsite and offshore team members in quality assurance standards, policies and procedures.
  • Drove corrective actions to accomplish project closure and recurrence control.

Sr. Staff Scientist Engineer / FDA Pre-Approvals Inspection QMS-QA Lead

Cordis LLC
08.2002 - 12.2004
  • Responsible for the new Product Technology Transfer from Latina, Italy to Miami Lake, FL, and from the Miami Lake, FL Plant to the San German, PR Plant Including, the Analytical Method Transfer/ and optimization of the new drug/device combined product, supported Quality Assurance and Quality Control laboratory activities, such as Laboratory Investigations, review, and disposition of OOS and LIR Programs and SOPs, Prepared the required documentation, ensuring the implementation of QMS, site readiness for the Pre-Approval Inspection and Regulatory Agencies inspections (FDA). Training, Writing SOPs, Laboratory Instrumentation IQ/OQ/PQ Protocol development, review, CAPAs (Trackwise), Document Control, and Change Control Management. Coordinator for the QA/QC Laboratory. In addition, Support the Regulatory Affairs submission activities including the review of the documentation before the submission to FDA.
  • Medical Devices
  • Mentored junior staff members in best practices while motivating them towards career advancement.
  • Enhanced customer satisfaction levels by improving responsiveness to inquiries or concerns.
  • Implemented quality control measures to ensure consistent excellence in products and services delivered to clients.
  • Led cross-functional teams to successfully deliver complex projects on time and within budget.
  • Presented at industry conferences as an expert thought leader, strengthening the brand reputation of the company in its field of expertise.
  • Successfully managed change initiatives throughout the organization during periods of significant transition and growth.
  • Spearheaded the implementation of innovative technologies, enhancing operational efficiency and reducing costs.
  • Streamlined internal communication channels to foster collaboration between departments and increase overall organizational effectiveness.
  • Consistently exceeded sales targets by cultivating strong relationships with clients and identifying new business opportunities.
  • Evaluated potential mergers or acquisitions to support long-term business objectives.
  • Reduced overhead expenses through cost-saving initiatives without compromising quality or employee morale.
  • Oversaw financial forecasting activities to inform executive-level decision-making processes.
  • Coordinated training programs for employees, boosting skillsets across multiple disciplines.
  • Negotiated contracts with vendors and suppliers, securing favorable terms that benefited the company''s bottom line.
  • Improved team productivity by streamlining processes and implementing new project management tools.
  • Championed diversity initiatives in hiring practices, building a more inclusive workplace culture that drove innovation and creativity.
  • Managed a high-performing team, providing mentorship, guidance, and professional development opportunities for staff members.
  • Assisted with onboarding new staff members, providing orientation and support.
  • Participated in team-building activities to foster teamwork and collaboration.
  • Responded sensitively and competently to service customers with diverse cultural backgrounds.
  • Greeted clients and guests and assisted with variety of questions to foster exceptional customer service.
  • Established positive relationships with customers and other staff members.
  • Kept work areas clean, organized, and safe to promote efficiency and team safety.
  • Provided guidance and support to junior staff members in achieving performance goals.
  • Liaised with management and other departments to maintain smooth operations.
  • Established and maintained strong relationships with colleagues through regular meetings and communication.
  • Developed and improved time management and organizational skills to maximise personal productivity.
  • Set and worked towards ambitious goals with staff performance plans and regular check-in meetings.
  • Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
  • Optimized customer experience by delivering superior services and effectively troubleshooting issues.
  • Developed effective improvement plans in alignment with goals and specifications.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Generated reports detailing findings and recommendations.
  • Helped meet changing demands by recommending improvements to business systems or procedures.
  • Frequently inspected production area to verify proper equipment operation.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
  • Observed packing operations to verify conformance to specifications.
  • Gathered, organized and input information into digital database.
  • Collected, arranged, and input information into database system.
  • Evaluated staff performance and provided coaching to address inefficiencies.
  • Maintained database systems to track and analyze operational data.
  • Educated staff on organizational mission and goals to help employees achieve success.
  • Created and managed project plans, timelines and budgets.
  • Devised and implemented processes and procedures to streamline operations.
  • Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
  • Supported creation of detailed, technical financial models to value potential acquisition targets.
  • Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
  • Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
  • Designed experiments using appropriate controls and variables, resulting in valid conclusions being drawn from collected data.
  • Implemented quality control measures to ensure the accuracy and reliability of experimental results.
  • Simultaneously managed several complex projects, meeting all pertinent milestones.
  • Evaluated emerging research trends, positioning organization at forefront of innovation.
  • Conducted in-depth data analysis to uncover hidden patterns, contributing to breakthroughs in scientific understanding.
  • Facilitated interdisciplinary research projects, merging diverse perspectives to tackle complex scientific questions.
  • Organized international scientific conferences, promoting knowledge exchange and networking.
  • Designed and delivered engaging scientific workshops, enhancing skill set of participants.
  • Optimized research processes for speed without sacrificing accuracy, setting new standards for team.
  • Enhanced laboratory efficiency by streamlining experimental protocols.
  • Translated complex scientific concepts into accessible presentations, broadening audience's understanding.
  • Secured competitive research grants, ensuring continuation and expansion of vital projects.
  • Contributed to development of patent, enhancing organization's intellectual property portfolio.
  • Fostered collaborations with international research teams, enriching scope of scientific inquiry.
  • Negotiated with suppliers to obtain high-quality materials at reduced costs, maximizing budget efficiency.
  • Pioneered use of cutting-edge technology in experiments, obtaining unprecedented data quality.
  • Mentored junior scientists, elevating overall expertise within team.
  • Spearheaded the design and execution of high-impact research projects, advancing field of study.
  • Led team in development of groundbreaking research methodology, significantly enhancing accuracy of experimental results.
  • Implemented rigorous quality control measures, guaranteeing reliability of research outcomes.
  • Spearheaded design and execution of high-impact research projects, advancing field of study.
  • Developed new chemical compounds with improved properties, meeting and exceeding project goals.
  • Conducted field research in challenging environments, expanding empirical base of study.
  • Increased research visibility, publishing findings in top-tier scientific journals.
  • Supervised biological technicians and technologists and other scientists.
  • Analyzed samples of blood and tissue for specific chemicals using automated testing procedures.
  • Monitored new drugs given to patients to treat conditions, noting dosage, efficacy and side effects.
  • Consulted with researchers to analyze problems, recommend technology-based solutions and determine computational strategies.
  • Maintained accurate records of all methods and research conducted and wrote in-depth medical reports.
  • Analyzed raw microarray data, genomic sequence data, and proteomics data for clinical or basic research purposes.
  • Followed strict safety protocols, protecting staff and assets while carrying out technical procedures and research protocols.
  • Developed new software applications and customized existing applications to meet specific scientific project needs.
  • Performed repetitive research tests in clinical environments.
  • Established strong working relationships with clients through exceptional communication skills, fostering trust and collaboration.
  • Wrote, reviewed and edited technical document in accordance with template requirements.
  • Developed positive working relationships with stakeholders to effectively coordinate work activities.
  • Reduced project completion time with efficient resource allocation and effective communication strategies.
  • Achieved successful project outcomes by maintaining accurate documentation and meeting strict deadlines.
  • Participated in formal internal design reviews of proposed products and components.
  • Optimized engineering processes by implementing innovative solutions and streamlining workflow.
  • Developed cost estimates and project specifications for proposals.
  • Provided input to team lead regarding areas for process and procedural improvement.
  • Conducted rigorous quality assurance tests, identifying areas of improvement for product optimization.
  • Collaborated on interdisciplinary teams to develop creative, cost-effective solutions for complex projects.
  • Reviewed technical drawings developed by CAD technicians and drafters.
  • Evaluated vendor proposals for equipment procurement, selecting optimal solutions based on performance requirements.
  • Presented technical findings to stakeholders, ensuring clear understanding of project status and goals.
  • Enhanced product performance by conducting thorough failure analysis and recommending improvements.
  • Conducted feasibility studies for new projects, providing detailed analysis and recommendations that informed leadership decisions.
  • Streamlined permit acquisition process for new projects, working closely with local authorities to ensure compliance and timely approval.
  • Optimized workflow and increased productivity by introducing cutting-edge engineering software for project management.
  • Improved client satisfaction with detailed progress reports and proactive communication during project execution phases.
  • Developed comprehensive maintenance schedule for critical machinery, extending equipment lifespan and minimizing production delays.
  • Achieved significant cost savings in material usage through development and application of innovative recycling program.
  • Enhanced safety protocols during construction projects, ensuring compliance with national standards and reducing workplace accidents.
  • Conducted detailed research and analysis to identify potential improvements in engineering methods, resulting in more sustainable practices.
  • Enhanced team performance by implementing structured onboarding program for new engineers, reducing ramp-up time.
  • Facilitated knowledge sharing sessions on latest engineering trends, fostering culture of continuous learning among team members.
  • Developed proprietary algorithm that enhanced data analysis capabilities, leading to more informed decision-making.
  • Initiated and led sustainability task force, integrating eco-friendly practices into engineering projects and reducing environmental impact.
  • Streamlined project delivery processes, implementing agile methodologies that improved team collaboration and efficiency.
  • Improved energy efficiency in manufacturing processes by redesigning mechanical systems and components.
  • Supported junior engineers through mentorship, offering guidance on complex problem-solving and technical skills development.
  • Coordinated with suppliers to secure high-quality materials, negotiating favorable terms that led to reduction in project costs.
  • Negotiated with suppliers to secure high-quality materials at cost-effective prices.
  • Conducted rigorous quality control checks, ensuring all engineering projects met internal and external quality standards.
  • Reduced downtime during system upgrades with thorough planning and implementation of new hardware across company networks.
  • Led cross-functional teams to innovate on product design, enhancing user experience and functionality.
  • Enhanced product reliability by leading team in meticulous design and testing of new engineering software tools.
  • Trained and mentored junior engineers, providing guidance and direction.
  • Collaborated with other departments to facilitate successful project completion.
  • Assisted in developing cost-effective solutions to engineering problems.
  • Created detailed reports on engineering activities and findings.
  • Documented and developed engineering procedures and processes.
  • Conducted technical evaluations of engineering designs and test results.
  • Developed and maintained relationships with suppliers to facilitate quality and timely delivery of materials.
  • Implemented new strategies to reduce costs and improve efficiency of engineering team.
  • Analyzed and interpreted customer requirements to develop engineering solutions.
  • Monitored and evaluated engineering performance to recommend improvements.
  • Verified construction documentation to meet client requirements and vision.
  • Conducted research to identify and evaluate new technologies and concepts.
  • Developed comprehensive engineering documents for all projects.
  • Developed and implemented procedures to verify compliance with engineering standards.
  • Led engineering teams to successfully complete projects on time and within budget.
  • Designed and implemented quality control processes to facilitate customer satisfaction.
  • Analyzed and interpreted data to identify trends and recommend improvements.
  • Developed high-quality engineering designs and plans to meet industry standards.
  • Implemented automated systems to improve accuracy and efficiency of engineering processes.
  • Performed complex calculations to analyze and optimize engineering processes.
  • Mentored junior team members, fostering growth and enhancing team performance.
  • Standardized bug reporting methods for better communication between QA and development teams.
  • Implemented automation tools, increasing testing accuracy and reducing manual effort.
  • Championed the adoption of best practices in QA methodologies throughout the organization.
  • Managed multiple projects simultaneously, ensuring timely delivery of high-quality products.
  • Reduced defect leakage by effectively conducting regression testing after each release cycle.
  • Facilitated seamless integration of new team members into ongoing projects through comprehensive training programs and documentation support.
  • Collaborated with development teams to resolve issues and implement improvements, elevating overall product quality.
  • Conducted root cause analysis on recurring defects, implementing preventative measures to reduce future occurrences.
  • Increased team productivity by continuously reviewing existing workflows and recommending enhancements.
  • Optimized test coverage by defining clear test objectives and prioritizing scenarios based on risk assessment.
  • Enhanced software quality by developing comprehensive test strategies and plans.
  • Streamlined QA processes for improved efficiency, reducing project completion time.
  • Led cross-functional teams to ensure seamless collaboration in achieving project goals.
  • Developed reusable test scripts for efficient execution across multiple platforms and environments.
  • Evaluated emerging trends and technologies in software testing to maintain a competitive edge in the market.
  • Established key performance indicators to measure the success of testing efforts and drive continuous improvement.
  • Ensured compliance with industry standards such as ISO 9000 or CMMI through diligent auditing of QA processes.
  • Updated quality control standards, methods, and procedures to meet compliance requirements.
  • Increased customer satisfaction through adherence to quality standards and customer requirements.
  • Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
  • Evaluated quality problems and performed assessments to identify and resolve issues.
  • Developed and deployed production control plans and created work instructions and procedures.
  • Improved quality processes for increased efficiency and effectiveness.
  • Mentored and encouraged employees to strive for excellence while fostering professional growth.
  • Inspected inbound and outbound products for compliance with established industry standards, company policies, and procedures.
  • Devised specifications for processes.
  • Managed and archived quality documentation and participated in internal and external quality audits.
  • Sorted product and provided expertise on non-conforming product requirements.
  • Wrote and implemented new rework procedures to standardize processes and streamline workflow.
  • Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
  • Provided observations, took measurements, and performed tests at various stages according to quality control plan.
  • Liaised with HR manager to organize and perform quality standard training for new and existing staff.
  • Calibrated instruments and scales in production area and quality lab.
  • Operated under Agile and Scrum frameworks to complete releases and well-organized sprints.
  • Monitored resolution of bugs, tested fixes, and helped developers tackle ongoing problems by providing QA perspective.
  • Tested functional and compatibility of new programs or updates in comparison to existing applications.
  • Documented testing procedures for developers and future testing use.
  • Gathered data on integration issues and vulnerabilities, reported findings and recommended improvements.
  • Built automated test scripts to handle repetitive software testing work.
  • Evaluated function, performance and design compliance of every product against design standards and customer needs.
  • Completed pre-implementation testing for new system modifications to assess potential impacts.
  • Developed and maintained defect databases for known issues.
  • Authored and maintained well-organized, efficient and successful manual test cases for entire team.
  • Kept scripts and test cases updated with current requirements.
  • Advised developers on problems with databases, performance and other issues.
  • Incorporated delivery requirements into planning of testing schedules.
  • Completed in-depth usability testing on Windows, Android and iOS mobile devices.
  • Recommended changes and corrections to developers for optimal software performance and usability.

QC & QA Director

Andrix Pharmaceuticals
09.2001 - 12.2002
  • Under the direction of the Vice President of Quality, US Quality and Compliance, Project Manager CSV - Managed multiple projects in support of Computer System Validation, business analysis, Quality Assurance & compliance, and decision support. He orchestrated all aspects of a project life cycle, including project planning, scope definition, requirements gathering, design, change control, user testing, implementation, customer relationships, training, and team leadership. The project included: TrackWise, ChemStation, LIMS, Nu Genesis, and Millennium.
  • Fort Lauderdale, FL September 2001 to July 2002
  • Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
  • Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
  • Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
  • Cultivated a positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.
  • Managed budgets effectively to ensure optimal use of resources while maintaining financial stability.
  • Facilitated cross-functional collaboration for improved decision-making processes within the organization.
  • Improved project efficiency with strategic planning, resource allocation, and time management practices.
  • Implemented innovative solutions to solve complex problems, resulting in increased productivity and streamlined operations.
  • Proactively identified potential risks and implemented mitigation strategies to minimize negative impacts on projects or business operations.
  • Leveraged professional networks and industry knowledge to strengthen client relationships.
  • Optimized staff performance by designing comprehensive training programs tailored to individual needs.
  • Negotiated favorable contracts with vendors for reduced costs and improved service quality.
  • Increased company revenue by streamlining processes and implementing cost-saving measures.
  • Boosted client satisfaction rates through exceptional relationship management and prompt resolution of issues.
  • Secured key partnerships that contributed to the company''s overall growth strategy and market reach.
  • Spearheaded successful product launches that resulted in increased brand visibility and customer acquisition.
  • Optimized inventory management to minimize costs and ensure product availability.
  • Revolutionized customer service protocols, significantly improving customer satisfaction ratings.
  • Transformed organizational culture to embrace continuous improvement, leading by example and mentoring teams.
  • Fostered culture of innovation, encouraging development of cutting-edge solutions.
  • Strengthened financial health with rigorous cost control measures and revenue enhancement strategies.
  • Enhanced stakeholder satisfaction with timely and transparent communication strategies.
  • Reinforced company's competitive position by securing intellectual property rights and fostering innovation.
  • Boosted operational efficiency by optimizing supply chain processes.
  • Expanded into new markets, conducting thorough market analysis and establishing key local partnerships.
  • Achieved remarkable turnaround of underperforming divisions through strategic leadership and restructuring.
  • Enhanced data-driven decision-making by implementing advanced analytics and reporting tools.
  • Navigated company through periods of significant change, maintaining focus on long-term strategic goals.
  • Improved team morale and productivity by implementing comprehensive professional development program.
  • Cultivated high-performance executive team, selecting and mentoring candidates for key leadership roles.
  • Elevated company profile in industry by spearheading comprehensive rebranding initiative.
  • Led cross-functional teams to exceed benchmarks for SLA delivery, staying on top of challenging schedules with multiple competing timelines.
  • Streamlined project delivery mechanisms, significantly reducing time to market for new initiatives.
  • Pioneered adoption of sustainable practices, leading to industry recognition and awards.
  • Drove significant market share growth with launch of innovative product lines.
  • Trained and guided team members to maintain high productivity and performance metrics.
  • Assisted in recruiting, hiring and training of team members.
  • Interacted well with customers to build connections and nurture relationships.
  • Recruited, hired, and trained initial personnel, working to establish key internal functions and outline scope of positions for new organization.
  • Cultivated and strengthened lasting client relationships using strong issue resolution and dynamic communication skills.
  • Observed each employee's individual strengths and initiated mentoring program to improve areas of weakness.
  • Implemented business strategies, increasing revenue, and effectively targeting new markets.
  • Handled problematic customers and clients to assist lower-level employees and maintain excellent customer service.
  • Tracked employee attendance and punctuality, addressing repeat problems quickly to prevent long-term habits.
  • Negotiated price and service with customers and vendors to decrease expenses and increase profit.
  • Reported issues to higher management with great detail.
  • Scheduled employees for shifts, taking into account customer traffic and employee strengths.
  • Tracked trends and suggested enhancements to both challenge and refine company's product offerings.
  • Managed purchasing, sales, marketing and customer account operations efficiently.
  • Identified and qualified customer needs and negotiated and closed profitable projects with high success rate.
  • Reduced budgetary expenditures by effectively negotiating contracts for more advantageous terms.
  • Implemented innovative programs to increase employee loyalty and reduce turnover.
  • Reduced financial inconsistencies while assessing and verifying billing invoices and expense reports.
  • Launched staff engagement, gender diversity and cultural programs in addition to robust reporting tool that increased operational quality.
  • Reduced operational risks while organizing data to forecast performance trends.
  • Updated and resolved incidents and managed accessorial charges objectively while maximizing profit.
  • Monitored daily cash discrepancies, inventory shrinkage and drive-off.
  • Supervised creation of exciting merchandise displays to catch attention of store customers.
  • Raised property accuracy and accountability by creating new automated tracking method.

Quality Assurance Director

Beiersdorf Inc.
09.1998 - 09.2001
  • Responsible for establishing a corporate quality assurance and compliance system and team that promotes customer satisfaction and positively impacts the quality performance of the company. Continuous Improvement Champion that ensures efforts and defect-reduction initiatives to establish an effective QI/PI system.
  • Cosmetic under cGMP operation
  • Conducted regular audits to ensure adherence to established protocols, maintaining consistency across the organization.
  • Investigated customer complaints and performed corrective actions to resolve quality issues.
  • Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
  • Established robust quality documentation systems that ensured traceability throughout the entire production lifecycle.
  • Conducted risk assessments to identify and mitigate potential quality issues.
  • Inspected products and worker progress throughout production.
  • Performed root cause analysis to identify and resolve quality issues and defects.
  • Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
  • Improved customer satisfaction ratings through meticulous attention to detail and consistent quality control measures.
  • Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
  • Recorded, analyzed, and distributed statistical information.
  • Created and maintained quality management systems to align with industry standards.
  • Managed supplier relationships, enforcing strict standards for incoming materials and components to preserve product integrity and minimize rejections.
  • Evaluated new technologies and methodologies for potential implementation within the organization''s quality assurance program, staying ahead of industry trends.
  • Reported production malfunctions to managers and production supervisors.
  • Improved customer satisfaction by ensuring all products met stringent quality standards before release.
  • Achieved significant reductions in return rates by focusing on early detection of manufacturing defects.
  • Initiated and managed relationships with suppliers to ensure raw materials met quality specifications.
  • Developed and implemented quality assurance dashboard, providing real-time visibility into quality metrics.
  • Analyzed customer feedback to identify quality trends and areas for improvement.
  • Conducted regular training sessions on quality assurance best practices, elevating team competency levels.
  • Established and tracked quality department goals and objectives.
  • Applied coaching techniques and tools to support managers and team members in improving performance.
  • Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
  • Trained team members on quality assurance principles, fostering a culture of accountability and high performance.
  • Facilitated communication between departments regarding quality concerns, fostering collaboration towards shared goals.
  • Enhanced product quality by implementing comprehensive QA processes and procedures.
  • Assured consistent quality of production by implementing and enforcing automated practice systems.
  • Mentored junior staff members in best practices for quality management, contributing to overall team growth and development.
  • Reduced defects in products by conducting thorough inspections and identifying areas for improvement.
  • Monitored staff organization and suggested improvements to daily functionality.
  • Played a crucial role in refining company manufacturing practices by providing expert guidance on regulatory compliance matters.
  • Championed continuous improvement initiatives, consistently seeking ways to optimize operations for better results.
  • Collaborated with cross-functional teams to develop and implement process and system improvements.
  • Streamlined testing processes by introducing automated tools, increasing efficiency and reducing errors.
  • Implemented new quality assurance and customer service standards.
  • Collaborated with cross-functional teams to identify root causes of product issues, leading to timely resolutions and continuous improvements.
  • Prevented costly recalls by proactively addressing potential risks before they escalated into larger issues.
  • Drove successful product launches with rigorous pre-release testing protocols that minimized post-launch issues.
  • Championed a customer-focused mindset across the organization by emphasizing the importance of consistently delivering high-quality products and services.
  • Streamlined defect tracking and resolution process, minimizing impact on production schedules.
  • Spearheaded adoption of automated testing tools, increasing test coverage and efficiency.
  • Collaborated with product development teams to integrate quality assurance principles early in design phase.
  • Led cross-functional teams to identify and resolve quality issues, fostering culture of continuous improvement.
  • Enhanced product quality and reduced defect rates by implementing comprehensive quality control processes.
  • Enhanced team productivity and morale by establishing clear goals and recognizing achievements.
  • Mitigated risk of non-compliance with industry regulations by maintaining up-to-date knowledge of standards and conducting regular audits.
  • Implemented supplier scorecard system, improving supplier performance and product quality.
  • Pioneered use of statistical analysis tools in quality assessments, leading to more data-driven decision-making.
  • Oversaw transition to new quality management system, ensuring minimal disruption to operations.
  • Negotiated with external certification bodies to ensure timely and cost-effective product certifications.
  • Reduced time to market for new products with streamlined testing protocols.
  • Facilitated knowledge sharing sessions on quality improvements, leading to widespread adoption of best practices.
  • Cultivated quality-centric mindset throughout organization, leading to fewer customer complaints.
  • Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
  • Tracked quality issues with external customers, suppliers, and internal plant operations.
  • Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
  • Determined quality department standards, practices, and procedures.
  • Specified quality requirements of raw materials with suppliers.

MS Associate Scientist

Procter & Gamble Pharmaceuticals
06.1998 - 08.1998
  • Responsible for sample preparation and analysis of compounds generated by combinatorial chemistry using a Mass Spectrometer (LC/MS) including troubleshooting and maintenance of laboratory instrumentation (LC/MS). Responsible for the analytical method development LC/MS and data analysis review.
  • September(May 1998 – August 1998)
  • Maintained a safe and organized laboratory environment by adhering to best practices for chemical handling and waste disposal.
  • Managed multiple projects simultaneously, demonstrating exceptional time management skills while maintaining high levels of accuracy.
  • Led training sessions on lab equipment usage for new hires, promoting a culture of continuous learning within the team.
  • Implemented quality control measures throughout the experimentation process to ensure the integrity of study outcomes.
  • Mentored junior scientists, providing guidance on experimental design and data analysis.
  • Developed and validated analytical methods to ensure accurate results in various assays.
  • Optimized laboratory processes by implementing new techniques and technologies to increase efficiency.
  • Evaluated novel materials or reagents for potential use in research projects, supporting informed decision-making within the team.
  • Conducted thorough literature reviews to stay current on industry advancements and inform research directions.
  • Established effective collaborations with external partners to leverage resources and expertise for project success.
  • Assisted with intellectual property filings by documenting experimental results meticulously according to company standards.
  • Presented research findings at scientific conferences, enhancing the reputation of the organization.
  • Maintained absolute integrity with report findings.
  • Produced statistical reports to correlate with laboratory research.
  • Trained newly hired employees on processes and procedures relevant to lab tasks at hand.
  • Troubleshot instrumentation issues, ensuring minimal downtime for critical experiments.
  • Contributed to grant proposals, securing funding for vital research initiatives.
  • Enhanced team productivity by streamlining workflows through process improvements and automation solutions.
  • Identified opportunities for cost reduction in laboratory operations without compromising on safety or reliability.
  • Conducted experiments in the laboratory environment for product development purposes.
  • Simultaneously managed several complex projects, meeting all pertinent milestones.
  • Documented changes during experiments, noting unexpected issues arising during research activities.
  • Documented all processes during experiments, keeping meticulous notes of changes that were unexpected.
  • Collaborated with cross-functional teams for the successful completion of projects, meeting deadlines and objectives.

Staff Chemist/Raw Material Specialist

Hoechst Marion Rouselle /Marion Merrill Dow
01.1994 - 05.1998
  • Responsible for the performance of raw material analysis using USP/NF, EP, BP, and ACS methods. Vendor audit and vendor qualification for the purchase of new Raw Material. In addition, troubleshooting, maintenance, calibration, and purchasing of laboratory instrumentation, SOPs writing and review.
  • Kept work areas clean, organized, and safe to promote efficiency and team safety.
  • Established positive relationships with customers and other staff members.
  • Responded sensitively and competently to service customers with diverse cultural backgrounds.
  • Developed strong relationships with clients through consistent communication and attentive customer service, resulting in increased overall satisfaction.
  • Trained new employees on company policies and procedures, contributing to a cohesive team atmosphere and improved overall performance.
  • Established and maintained strong relationships with colleagues through regular meetings and communication.
  • Developed and improved time management and organizational skills to maximize personal productivity.
  • Supported the professional development of team members by regularly sharing best practices, encouraging ongoing learning, and promoting a culture of continuous improvement.
  • Analyzed performance data to identify trends and areas for improvement.
  • Managed complex schedules and logistics for executive meetings, ensuring all materials were prepared in advance.
  • Increased team productivity with introduction of flexible work-from-home policy.
  • Developed and maintained secure, up-to-date database for tracking project progress.
  • Conducted thorough market research to inform strategic planning sessions.
  • Improved project completion rates by implementing agile methodologies.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Gathered, organized and input information into digital database.
  • Evaluated staff performance and provided coaching to address inefficiencies.
  • Collected, arranged, and input information into database system.
  • Frequently inspected production area to verify proper equipment operation.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Developed effective improvement plans in alignment with goals and specifications.
  • Devised and implemented processes and procedures to streamline operations.
  • Created and managed project plans, timelines and budgets.
  • Supported creation of detailed, technical financial models to value potential acquisition targets.
  • Developed laboratory testing programs and data analysis while adhering to SOPs, ECOs, batch records and work instructions.
  • Coordinated and performed analytical tests to comply with established standards and specifications.
  • Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.
  • Performed standardized tests on organic and inorganic compounds to observe fundamental differences in properties.
  • Managed multiple projects simultaneously, ensuring timely completion within budget constraints while maintaining high-quality output standards.
  • Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
  • Maintained organized, safe and efficient laboratory environment to minimize accidents and prevent cross contamination.
  • Modified and adapted standard methods and procedures to solve analytical problems.
  • Prepared waste drums for pick-up and delivery to comply with local, state and federal regulations for treatment and disposal of hazardous waste.
  • Established quality control measures for instrumentation and monitored data quality to operate instrument with control limits.
  • Increased laboratory efficiency by implementing new software programs for data analysis and management.
  • Improved safety, conducting thorough risk assessments for laboratory procedures and chemical handling.
  • Reduced waste and improved resource utilization by implementing green chemistry principles in product development.
  • Developed custom chemical solutions for specific client needs, fostering strong customer relationships and enhancing satisfaction.
  • Conducted environmental impact assessments for chemical processes, ensuring compliance with environmental regulations and sustainability goals.
  • Developed and maintained accurate records of experimental data, contributing to the integrity and reproducibility of research findings.
  • Improved laboratory efficiency with the implementation of robust safety protocols and training sessions.
  • Conducted comprehensive chemical analyses for quality control, ensuring adherence to industry and safety standards.
  • Identified and resolved technical issues in production processes, ensuring uninterrupted operations and product quality.
  • Developed comprehensive training programs for new hires, ensuring a thorough understanding of departmental operations and procedures.
  • Conducted root cause analysis on recurring material issues, implementing corrective actions to prevent recurrence
  • Conducted root cause analysis on recurring material issues, implementing corrective actions to prevent recurrence.s.
  • Provided support during audits, compiling necessary documentation related to material sourcing and handling practices.
  • Served as a subject matter expert within the organization on matters related to materials management best practices and regulatory compliance requirements.
  • Increased productivity through effective resource allocation, prioritizing tasks according to criticality and available resources.
  • Managed incoming inspection activities to ensure materials met quality standards prior to acceptance into inventory or use in production lines.
  • Performed daily floor walks and supervised the receiving docks to investigate and resolve material issues.
  • Managed stockroom service desk and off-site warehouse, documenting and researching inaccuracies to determine the best corrective actions.
  • Identified issues and developed solutions to improve quality control.
  • Performed root cause analysis to implement corrective actions for discrepancies.
  • Performed calibrations and adjustments on measuring instruments for accurate results.
  • Used calipers, micrometers, and rulers to measure products, maintaining accurate records.
  • Used calipers, micrometers, and rulers to measure products, maintaining accurate records.
  • Collaborated with a 29-person team to develop long-range material demand plans and used gathered intelligence to work with suppliers to secure production reservations.

Ion Chromatography Analytical Chemist

Rhone – Poulenc Inc
08.1991 - 12.1993
  • Transferred from Manati, PR as an Ion Chromatography Analytical Chemist, responsible for method development on food ingredient compounds using Ion Chromatography Technology—troubleshooting and maintenance of laboratory instrumentation.
  • Hire- Relocated to NJ
  • Assisted clients with troubleshooting issues related to analytical testing during technical consultation sessions.
  • Developed and optimized sample preparation techniques to ensure accurate results while minimizing potential contamination.
  • Examined inoperative or malfunctioning production equipment to diagnose source of trouble.
  • Performed analysis of pharmaceutical finished products using various methods to test for purity.
  • Collaborated with supervision, engineering, and other personnel on quality and performance improvements.
  • Improved accuracy of results by maintaining calibration records and performing routine instrument maintenance.
  • Mentored junior chemists on best practices, contributing to their professional growth and success within the organization.
  • Troubleshot equipment adjustments to meet and maintain safety, output and quality expectations.
  • Developed innovative analytical methods for characterizing new materials, aiding in successful product launches.
  • Presented findings at conferences and published research articles in peer-reviewed journals, showcasing expertise within the field of analytical chemistry.
  • Established strong relationships with vendors to obtain high-quality chemicals and supplies at competitive prices while meeting project deadlines.
  • Created spreadsheets and other forms of documentation to accurately record and calculate analytical results.
  • Communicated analysis results to various departments and stakeholders to effectively formulate products.
  • Developed methodologies to identify pesticide residues in pharmaceutical products.
  • Calibrated and maintained laboratory spectrometers and chromatographs.
  • Maintained a clean, organized laboratory environment, promoting efficiency and adherence to safety standards.
  • Contributed to cost-saving initiatives by identifying opportunities for more efficient use of resources within the laboratory setting.
  • Enhanced team productivity through effective communication of goals, expectations, and feedback during regular progress meetings.
  • Streamlined data interpretation processes by utilizing statistical software tools to analyze large datasets efficiently.
  • Enhanced analytical capabilities by implementing advanced chromatographic and spectroscopic techniques.
  • Spearheaded validation studies for newly installed instrumentation, ensuring accurate performance before incorporating it into daily operations.
  • Assisted in the creation of a safer work environment by developing and enforcing laboratory safety protocols.
  • Reduced analysis timeframes by optimizing method development for various chemical compounds.
  • Increased lab efficiency through the implementation of quality control procedures and data management systems.
  • Collaborated with cross-functional teams to solve complex, industry-specific challenges in product development and manufacturing processes.
  • Identified potential areas for improvement in existing methodologies, leading to increased reliability in obtained data.
  • Supported regulatory compliance efforts by keeping up-to-date with changing industry standards and updating laboratory procedures accordingly.
  • Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
  • Contributed to team discussions and new project initiatives to advance progress and optimize profitability.
  • Repaired, calibrated and safely operated laboratory equipment to reduce costly instrument downtime.
  • Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.
  • Coordinated and performed analytical tests to comply with established standards and specifications.
  • Developed laboratory testing programs and data analysis while adhering to SOPs, ECOs, batch records and work instructions.
  • Carried out laboratory tests and experiments to analyze, identify and isolate chemical compounds.
  • Assisted with collecting, identifying and packaging hazardous and non-hazardous waste products to comply with Resource Conservation and Recovery Act regulations.
  • Modified and adapted standard methods and procedures to solve analytical problems.
  • Performed standardized tests on organic and inorganic compounds to observe fundamental differences in properties.

Analytical Chemist

Rhone – Poulenc Inc.
01.1990 - 07.1991
  • Responsible for the analytical testing of the raw material, in-process, stability samples, and finished products using HPLC, IC, GC, and wet chemistry.
  • Temp to Hire
  • Performed analysis of pharmaceutical finished products using various methods to test for purity.
  • Developed and optimized sample preparation techniques to ensure accurate results while minimizing potential contamination.
  • Assisted clients with troubleshooting issues related to analytical testing during technical consultation sessions.
  • Improved accuracy of results by maintaining calibration records and performing routine instrument maintenance.
  • Presented findings at conferences and published research articles in peer-reviewed journals, showcasing expertise within the field of analytical chemistry.
  • Developed innovative analytical methods for characterizing new materials, aiding in successful product launches.
  • Established strong relationships with vendors to obtain high-quality chemicals and supplies at competitive prices while meeting project deadlines.
  • Created spreadsheets and other forms of documentation to accurately record and calculate analytical results.
  • Developed methodologies to identify pesticide residues in pharmaceutical products.
  • Supported regulatory compliance efforts by keeping up-to-date with changing industry standards and updating laboratory procedures accordingly.
  • Identified potential areas for improvement in existing methodologies, leading to increased reliability in obtained data.
  • Maintained a clean, organized laboratory environment, promoting efficiency and adherence to safety standards.
  • Increased lab efficiency through the implementation of quality control procedures and data management systems.
  • Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
  • Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.
  • Coordinated and performed analytical tests to comply with established standards and specifications.
  • Developed laboratory testing programs and data analysis while adhering to SOPs, ECOs, batch records and work instructions.
  • Modified and adapted standard methods and procedures to solve analytical problems.
  • Performed standardized tests on organic and inorganic compounds to observe fundamental differences in properties.
  • Examined inoperative or malfunctioning production equipment to diagnose source of trouble.
  • Collaborated with supervision, engineering, and other personnel on quality and performance improvements.
  • Mentored junior chemists on best practices, contributing to their professional growth and success within the organization.
  • Troubleshot equipment adjustments to meet and maintain safety, output and quality expectations.
  • Communicated analysis results to various departments and stakeholders to effectively formulate products.
  • Reduced analysis timeframes by optimizing method development for various chemical compounds.
  • Spearheaded validation studies for newly installed instrumentation, ensuring accurate performance before incorporating it into daily operations.
  • Enhanced analytical capabilities by implementing advanced chromatographic and spectroscopic techniques.
  • Collaborated with cross-functional teams to solve complex, industry-specific challenges in product development and manufacturing processes.
  • Contributed to cost-saving initiatives by identifying opportunities for more efficient use of resources within the laboratory setting.
  • Streamlined data interpretation processes by utilizing statistical software tools to analyze large datasets efficiently.
  • Enhanced team productivity through effective communication of goals, expectations, and feedback during regular progress meetings.
  • Assisted in the creation of a safer work environment by developing and enforcing laboratory safety protocols.
  • Contributed to team discussions and new project initiatives to advance progress and optimize profitability.
  • Repaired, calibrated and safely operated laboratory equipment to reduce costly instrument downtime.
  • Carried out laboratory tests and experiments to analyze, identify and isolate chemical compounds.
  • Assisted with collecting, identifying and packaging hazardous and non-hazardous waste products to comply with Resource Conservation and Recovery Act regulations.

Education

MS - Thermodynamics, and Materials Sciences Engineering

University of Cincinnati
Cincinnati, OH
01.1997

Bachelor of Science - Chemical Engineer

University of Puerto Rico
Mayaguez, PR
01.1990

Master of Science - Analytical Chemistry

University of Puerto Rico
Mayaguez PR
01.1987

Ph.D. - Neuroscience With Neurotheology Application

Christian Neurotheology University of Puerto Rico
Caguas, Puerto Rico
10-2026

Skills

  • Plant Start-Ups
  • Regulatory Compliance Remediation (Warning Letters, 483s, and Consent Decrees
  • Quality Management System (QMS) Implementation and Remediation
  • Multi-Faceted Roles
  • Regulatory Compliance Readiness
  • Technology Transfer in a Pharmaceutical Setting
  • Regulatory Compliance & Remediation
  • Technology Transfer in a Biotech/Biosimilars Setting
  • Regulatory Affairs Submissions: INDs/NDA, ANDA,
  • Cell & Gene Therapy
  • Regulatory Affairs Labeling
  • Continuous Flow and Continuous Manufacturing
  • Process Improvement
  • CAPA, Change Controls, Document Control, Root Cause Analysis, Customer Relationship & Vendor Management, Out-of-Specification (OOS), Deviations, Complaint Investigation, and Field Actions
  • Risk Management Risk Assessment
  • Equipment Validation: Aseptic Filling/Isolators, Bioreactors, Chromatography Skids, etc
  • Utility Equipment Validation, Site Qualification
  • Qualification and Validation -IQ/OQ/PQ/SDLC
  • GXP - BLA
  • CSV/Data Integrity/CFR Part 11
  • ISO9001, ISO 13485, ISO 20691,
  • FDA - EMA, ANVISA, COFEPRIS
  • 21 CFR Part 210 and 211, 21 CFR Part 312, 21 CFR 610, 21 CFR Part 11
  • Certified Quality System Auditor (CQA)
  • Certified Quality Engineer (CQE)
  • CMC regulatory strategies/ CMC dossiers

Accomplishments

  • Featured in Forbes: Recognized in Forbes article “12 Times Women Made History in Science, Politics, and Justice in 2020” for impactful contributions to science and healthcare.
    Link to article
  • Regulatory Excellence:
    Led Quality Assurance (QA) efforts for a 483 remediation and FDA readiness project at a biosimilar manufacturing site in India.
    Directed QA activities under a Consent Decree remediation project, ensuring robust compliance and audit readiness.
    Developed and implemented QMS frameworks for pharmaceutical startups and international operations, including sites in the U.S. and Brazil (ANVISA Inspection Readiness).
  • Leadership Roles:
    Served as Head of Quality for Cell & Gene Therapy operations, providing oversight across validation, compliance, and quality systems.
    Acted as Commissioning Lead, overseeing commissioning support for laboratories, facilities, and pilot plant operations.
  • Regulatory & Inspection Preparedness:
    Prepared multiple sites for FDA, EMA, and ANVISA inspections, including Pre-Approval Inspections (PAIs).
    Led GMP Gap Assessments across QA, packaging, manufacturing, engineering, chemical and microbiology laboratories.
  • Complaints & Medical Device Reporting (MDR):
    Led the investigation and response of 658+ customer complaints and over 980 retrospective MDR submissions for a German company under FDA Warning Letter.
  • Audit & Compliance Oversight:
    Conducted internal audits and led cross-functional Investigation Review Boards and Investigation Status Meetings.
    Authored comprehensive Quality Technical Assessment Reports, regulatory observation responses, and validation lifecycle documentation.
  • Validation & Technology Transfer:
    Directed and approved validation documentation including protocols, change controls, SOPs, investigations, and final reports.
    Successfully managed and delivered validation projects for pharmaceutical companies across the U.S. and Puerto Rico.
    Led technology transfer initiatives from Germany to U.S.-based sites, including analytical method transfers.
  • Regulatory Documentation:
    Responsible for reviewing and contributing to ANDA, NDA, and IND submissions to the FDA.
    Conducted thorough reviews of 510(k) documentation for medical device product lines.

Certification

  • Continues Flow and Continuous Manufacturing Certification (UPR- RUM)
  • PMP- Project Management Institute Certification
  • Hold a PE License for the States of FL, OH, CT, & NJ.
  • Member of the College of Chemist of Puerto Rico (Colegio de Quimicos de PR) Professional Chemistry License
  • Quality Engineer Certification (CQE)
  • Certified Quality Auditor (CQA)
  • Total Quality Management (TQM)
  • Supervisor & Manager leadership.
  • Situational Leadership
  • Train the Trainer
  • Data Entry, JMP
  • Certified for Internal Audits (ISO1 and 2/GMP/QSR/EN)
  • Operation Excellence
  • Trained the Quality Assurance team on the utilization of RC Tools for fishbone, 5Y, and other trend analyses.

Languages

English
Native or Bilingual
Spanish
Native or Bilingual
Italian
Full Professional

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote

My greatest glory is not in never falling, but rising every time I fall~unless you have a vision, you haven't begun to do the practice that make you great!
Mayra Liz

Timeline

Quality Assurance Auditor

Allergan Pharmaceuticals
06.2024 - 03.2025

Plant Manager

LeaRis KN Life Science
11.2022 - 12.2023

Head of Quality and Regulatory

Geniuxs Pharmaceuticals
04.2022 - 10.2022

Head of Quality Continuous Flow-Manufacturing

Brightpath Laboratories
08.2021 - 04.2022

CEO General Manager

GK Pharmaceuticals CDMO
12.2016 - 07.2021

Quality System Improvement Specialist

Intas Pharmaceuticals
03.2016 - 11.2016

Sr. Project Manager

Gilead Science Corp.
07.2015 - 03.2016

Complaint Coordinator

Maquet Getinge Group
10.2014 - 06.2015

Quality Systems Implementation Champion - SME

Aerie Pharmaceuticals
06.2014 - 07.2015

Regulatory Compliance Auditor

DePuy Synthes
11.2013 - 06.2014

QMS Remediation SME

McNeil Pharmaceuticals
04.2012 - 06.2013

Consent Decree Specialist QA Lead for Laboratory Controls

Genzyme Corp.
03.2012 - 02.2013

Regulatory Affairs Labeling Manager

Pfizer Pharmaceuticals USA
03.2009 - 11.2012

Regulatory Affairs Specialist Labeling/Project Manager

St Jude Medical Berlin, NJ
01.2009 - 12.2009

Regulatory Affairs/Quality Control / R&D Labeling Director

Bio-Pharm, Inc.
05.2007 - 12.2008

Project Lead/CSV – Consultant

Johnson & Johnson
04.2006 - 09.2007

Project Manager/ Computer System Validation Specialist

Sharp Corporation
01.2006 - 05.2006

Owner - Quality Management System SME

GK Regulatory Compliance
08.2005 - 12.2016

Sr. Project Manager - Laboratory & Computer System

Par Pharmaceutical
08.2004 - 12.2006

Sr. Staff Scientist Engineer / FDA Pre-Approvals Inspection QMS-QA Lead

Cordis LLC
08.2002 - 12.2004

QC & QA Director

Andrix Pharmaceuticals
09.2001 - 12.2002

Quality Assurance Director

Beiersdorf Inc.
09.1998 - 09.2001

MS Associate Scientist

Procter & Gamble Pharmaceuticals
06.1998 - 08.1998

Staff Chemist/Raw Material Specialist

Hoechst Marion Rouselle /Marion Merrill Dow
01.1994 - 05.1998

Ion Chromatography Analytical Chemist

Rhone – Poulenc Inc
08.1991 - 12.1993

Analytical Chemist

Rhone – Poulenc Inc.
01.1990 - 07.1991

MS - Thermodynamics, and Materials Sciences Engineering

University of Cincinnati

Bachelor of Science - Chemical Engineer

University of Puerto Rico

Master of Science - Analytical Chemistry

University of Puerto Rico

Ph.D. - Neuroscience With Neurotheology Application

Christian Neurotheology University of Puerto Rico

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