Versatile scientific professional with a background in conducting data analysis in highly regulated life science and fast-paced manufacturing environments. Dedicated professional with a Bachelor of Science in Biology, Master of Business Administration, and Master of Science in Science Management & Leadership. Ability to write and approve new SOPs and protocols. High attention to detail in conducting and analyzing scientific data for database management. Ability to collaborate with different groups and technical managers to process documentation analysis and requirements. Skilled in promoting team productivity through excellent communication and collaboration. Competent in defining test parameters, conducting evaluations and gathering data to identify defects.
Overview
7
7
years of professional experience
Work History
Quality Assurance Supervisor
Coca-Cola, Southwest Beverages
02.2023 - Current
Addressed non-conformance issues, pausing production to correct errors.
Implemented process improvements to increase productivity in quality assurance operations.
Fixed identified issues to improve workflows.
Liaised with vendors and end-users to uncover system optimization opportunities.
Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
Applied coaching techniques and tools to support managers and team members in improving performance.
Implemented new quality assurance and customer service standards.
Recorded, analyzed, and distributed statistical information.
Inspected products and worker progress throughout production.
Manage day-to-day operations of Equipment Fulfillment Center
Responsible for training, coaching and development of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of HR and or local policies
Responsible for execution of processes to ensure KPI goals are met
Oversee onboarding and training of new employees to promote qualified and well-coordinated quality assurance team.
Assessed investigation reports of subordinate quality assurance personnel and addressed any procedural deviations.
Analyzed quality and performance data to support operational decision-making.
Educated employees on specific QA standards and confirmed maintenance of standards.
Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
Fixed identified issues to increase productivity and boost workflows.
Determined quality department standards, practices, and procedures.
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.
Specified quality requirements of raw materials with suppliers.
Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
Assured consistent quality of production by implementing and enforcing automated practice systems.
Regulatory Expert
MilliporeSigma
10.2022 - 02.2023
Datamining activities for material containing animal by-products, genetically modified organisms, and microorganisms
Utilize digital expertise and collaboration to accelerate the use of digital assets
Manage data, and export document templates and systems
Participate as the Regulatory Representative in the new product introduction process to ensure proper data is collected and assess data and collaborate with colleagues regarding import/export requirements
Support negotiations and fulfill regulatory requirements with suppliers and customers
Collaborate with other digital experts, IT developers, and data specialists to accelerate the use of digital assets, best practices, and solutions
Utilize systems such as SAP, JIRA, Access, Excel, Trackwise
Advise users on their digital shift journey
Assist in driving cultural change by ensuring initiatives are leveraging agile techniques, design thinking, and digital solutions.
Performed and documented quality control checks to maintain compliance with company initiatives.
Prepared and submitted regulatory file applications and supporting documentation.
Received, researched and resolved consumer inquiries.
Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
Provided pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
Senior Associate QA Specialist
MilliporeSigma
08.2021 - 10.2022
Write, review, and approve standard operating procedures, specifications, master manufacturing procedures, and other QA-controlled documents
Ensure all aspects of product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems
Release equipment for use within manufacturing, verifying all cleaning meets specifications
Release raw materials for use within manufacturing, verifying all requirements have been met regarding analytical/biological testing and documentation
Collaborate with management and supervisory personnel from Operations, Quality Control, and Quality Assurance to resolve problems affecting product quality
Participate in audits
Ensures deviations and CAPAs are compliant to GMP and managed to completeness in a timely manner within TrackWise
Ensures the Change control programs follow adherence to GMP and closure times and the management of TrackWise.
Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
Supervisor
United Parcel Service
08.2021 - 12.2021
Manage department resources to ensure maximum output, accuracy, and efficiency always
Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows.
Handled customer complaints, resolved issues, and adjusted policies to meet changing needs.
Monitored workflow to improve employee time management and increase productivity.
Achieved results by working with staff to meet established targets.
Enforced rules and regulations outlined in company manual to set forth expectations comprehensibly and consistently.
Created successful work schedules for each team member to maintain deadlines and fully staff shifts.
Direct daily transload activities to support account objectives for level of service, cost management, customer expectations, and volume requirements
Ensure that all department and/or corporate policies and procedures are communicated, understood, and adhered to
Establish and promote a positive, team-oriented work environment emphasizing employee involvement, pro-active communication, inter-departmental cooperation
Implement employee personal development plans as required to ensure the continuing professional growth of department personnel
Establish and maintain an aggressive cross-training program within the department to promote development, enhance flexibility
Function as an effective liaison and advocate on all levels to ensure that employee, department, and corporate needs are addressed in a timely and productive manner.
Identified unsafe or unhealthful workplace conditions or hazards to enforce safe work practices and procedures.
Boosted team performance by developing customer service training materials and conducting service training.
Developed and implemented customer service policies to enhance satisfaction.
Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
Evaluated staff performance and provided coaching to address inefficiencies.
Maintained database systems to track and analyze operational data.
Senior Associate Production Scientist
MilliporeSigma
06.2020 - 08.2021
Perform routine and non-routine chemical manufacturing
Follow established protocols and procedures; to accurately prepare complete and legible records
Improve processes through the application of scientific knowledge, experience, and principles
Train personnel and act as a technical consultant as needed
Utilize systems such as Mango, Trackwise, SAP
Complete the volume of work required to achieve group/departmental goals and meet deadlines
Perform root cause analysis
Lead various projects and processes
Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
Simultaneously managed several complex projects, meeting all pertinent milestones.
Worked as member of integrated project team in highly collaborative work environment.
Conducted document review, organization and quality control of data acquisition to draw relevant conclusions and direct research activities.
Write new protocols and procedures
Perform and interpret analytical evaluations of products and intermediates
Manufacturing Engineering Technician III
Curium Pharma
10.2019 - 06.2020
Ensures a safe and quality working environment through training, awareness, compliance, regulatory, and safety guidelines
Provide directional leadership on the floor
Write, implement, and follow SOP’s and FDA regulations
Responsible for reviewing data reporting and implementing templates, utilizing LIMS and Excel as reporting tools
Coordinate with different departments and supervisors to plan, schedule, and execute all aspects of the area, formulate chemical solutions, and create experimental formulas
Utilizes programs such as MetricStream, LIMS, CitrixReceiver, Trackwise, and Microsoft Office Suite to track inventory data and environmental monitoring
Performs batch record entries and maintains all documentation according to cGMP Guidelines
Communicates effectively with coworkers and assists and supports investigations, kaizens, and reliability team meetings
Sets up, operates, monitors and cleans production equipment and ensures processes are in accordance with cGMPs and SOPs
Tracks orders and maintains the inventory in the lab
Demonstrates and qualifies employees for processes and procedures
Reviews logbooks and Excel spreadsheets and assists with CAPA, developing and revising SOPs and batch records.
Analyzed data collected to streamline processes.
Performed concurrent design and manufacturing engineering and other functions to reduce time required to bring product to market.
Eliminated ineffective product line materials to resolve performance challenges and mitigate corrosion.
Designed floor plans and layouts to maximize efficiency.
Inspected finished products for quality and adherence to customer specifications.
Inspected products and machines to maintain quality and efficiency.
Calibrated machines to maintain required productivity levels and adherence to quality standards.
Mapped process workflows to enhance understanding of procedures.
Aseptic Filling/Clean and Prep Operator
Pfizer
03.2017 - 10.2019
Produced pharmaceutical components and products, followed aseptic procedures, and documented actions in a clean room environment
Class A/B gowning qualified for facility cleaning of aseptic fill suites
Knowledgeable of cGMPs and assured that everything in the batch record was being documented correctly
Properly documented all required entries of batch records, Excel spreadsheets, logbooks, and sterilization records including proper performance and documentation of in-process checks
Performed and documented verification of other technicians on batch records and sterilization records
Cleaned equipment, performed, and documented line clearances, and received and verified components.
Used problem-solving and issue-resolution skills to promptly and successfully address production problems.
Trained new production staff members on safe and efficient production procedures and proper machine operations.
Examined incoming materials and compared to documentation for accuracy and quality.
Collaborated with other departments to optimize production workflows.
Education
Master of Science - Science Management and Leadership
Webster University
03.2023
MBA - Business Administration
Webster University
St Louis, MO
03.2023
Bachelor of Science - Biology
Harris Stowe State University
12.2017
Skills
Cause and Effect Analysis
Defect Documentation
Information Assurance
Vendor Relations
Motivational Leadership
Compliance with GMPs
Active Listening
Project Management
Equipment Use
Sound Decision-Making Abilities
Corporate Social Responsibility
Problem-Solving Skills
Correction Action Planning
Quality Improvement
Key Performance Indicators (KPIs)
Process and Performance Improvement
Production Optimization
Verbal and Written Communication
Goal Attainment
Personnel Management
Job Assignments
Stakeholder Communications
Compliance Certifications
Audit Reports
Team Leadership
Complex Problem-Solving
Technical Documentation
Multi-Factor Authentication
Personnel Scheduling
ISO 9000 Requirements
Organizational Systems
Internal Audits
Timeline
Quality Assurance Supervisor
Coca-Cola, Southwest Beverages
02.2023 - Current
Regulatory Expert
MilliporeSigma
10.2022 - 02.2023
Senior Associate QA Specialist
MilliporeSigma
08.2021 - 10.2022
Supervisor
United Parcel Service
08.2021 - 12.2021
Senior Associate Production Scientist
MilliporeSigma
06.2020 - 08.2021
Manufacturing Engineering Technician III
Curium Pharma
10.2019 - 06.2020
Aseptic Filling/Clean and Prep Operator
Pfizer
03.2017 - 10.2019
Master of Science - Science Management and Leadership