Shantel Haynes

• Manage both external & external audit compliance activities integral to applicable QMS regulation's and product quality effectiveness requirements.
• Oversee all aspects of Supply Chain processes in efforts to ensure purchased product(s) meet designated QMS approval specifications prior clinical/human
• Played instrumental role in company-wide risk assessment efforts, supporting enhancements in business processes and controls.
• Delivered subject matter expertise for internal and external customers on compliance best practices and quality control.
• Evaluated customer complaints, processes and all other aspects of operations to assess compliance.
• Conducted quarterly audits of environmental management compliance.
• Verified consistency in quality planning, quality control, quality insurance and quality improvement.
• Consulted with clients on best practices and served as project manager for all process improvements and regulatory initiatives.
• Defined and developed policies and procedures for consumer reporting and privacy practices.
• Formulated detailed recommendations based on audit findings to support annual planning and definition of goals.
• Advised division leaders of regulatory risks in business processed and provided recommendations for improvement.
• Publicized health and safety program requirements and mentored employees on critical nature of compliance.
• Drove optimization of regulatory risks management, control testing and process improvements.
• Executed corporate food safety strategies, policies and procedures.
• Supported marketing team in review and submission of regulatory articles and newsletters.
• Collaborated with contract team to review client contracts and facilitate personnel compliance training.
• Supervised and coached compliance personnel in mortgage and home equity, vehicle lending, credit card services and deposits monitoring.
• Kept new and modified products and services in conformance with security and compliance regulations.
• Monitored key food safety KPIs and prepared evaluations, assessments and reports.
• Backed data security and information privacy efforts.
• Facilitated company-wide review of personnel wage and hour practices.
• Managed company participation in food safety audits, and reviews by third parties, customers and regulatory agencies.
• Streamlined compliance processes by implementing efficient monitoring systems and tools.
• Monitor and project overall QMS objective status via KPI and Management Review meetings

and formalize required practices to ensure CAPA / Complaint / NCR activities are applied per required processes.

• Maintained effective working relationships with regulatory authorities, suppliers and customers.
• Reviewed documents, files, transcripts and other records to assess compliance and potential risk.
• Apply Risk Analysis processes upon market release product line
• Collaborated with cross-functional teams to establish clear compliance guidelines and expectations for all departments.
• Improved communication channels between departments by establishing regular meetings and reporting structures related to compliance matters.
• Enhanced overall business operations by continuously improving policies, procedures, and controls related to compliance requirements.
• Achieved optimal results during external audits by diligently preparing documentation and providing evidence of strong internal controls.
• Succeeded in maintaining a positive relationship with regulators through proactive engagement and timely responses to inquiries.
• Provided expert advice to senior management on potential risks, legal implications, and recommended solutions for complex compliance issues.
• Supported the implementation of new regulations within the organization by developing strategic plans and action items for each department.
• Managed investigations into potential violations of laws or regulations, ensuring swift resolution and corrective actions when necessary.
• Strengthened company-wide awareness of relevant laws, regulations, and industry standards through targeted trainings, presentations, and ongoing communication efforts.
• Monitored emerging trends in regulatory requirements, anticipating potential impacts on the organization''s operations.
• Evaluated third-party vendors'' adherence to applicable laws/regulations before engaging them as partners or service providers for the company''s projects.
• Assisted in developing and implementing a robust ethics program, fostering a strong culture of integrity and compliance throughout the company.
• Reviewed business contracts for compliance with regulatory requirements, minimizing legal exposure and ensuring all commitments were met.
• Oversaw a team of compliance professionals, providing guidance, mentorship, and support to ensure their continued growth and development.
• Performed regular compliance reviews and audits, identifying non-compliance issues.
• Addressed compliance issues by developing and implementing corrective action plans.
• Implemented effective compliance policies and procedures to meet regulatory requirements.
• Analyzed and identified risk areas to determine compliance with applicable laws and regulations.
• Established and monitored compliance procedures to provide consistent implementation across departments.
• Investigated potential compliance violations and reported findings to senior management.
• Developed compliance training initiatives and materials, educating staff on regulations.
• Kept up to date on compliance trends and rulings using meticulous research and study.
• Devised and maintained compliance recordkeeping processes to support initiatives.
• Skilled at working independently and collaboratively in a team environment.
• Self-motivated, with a strong sense of personal responsibility.
• Worked well in a team setting, providing support and guidance.
• Worked effectively in fast-paced environments.
• Managed time efficiently in order to complete all tasks within deadlines.
• Demonstrated respect, friendliness and willingness to help wherever needed.
• Excellent communication skills, both verbal and written.
• Passionate about learning and committed to continual improvement.
• Proved successful working within tight deadlines and a fast-paced environment.
• Proven ability to learn quickly and adapt to new situations.
• Improved quality compliance by developing and implementing effective policies and procedures.
• Enhanced operational efficiency by streamlining quality assurance processes and documentation.
• Reduced non-conformance incidents through thorough root-cause analysis and corrective actions.
• Achieved higher customer satisfaction levels by monitoring supplier performance and ensuring adherence to quality standards.
• Collaborated with cross-functional teams for continuous improvement initiatives, resulting in increased product reliability.
• Conducted comprehensive audits to identify gaps in compliance, leading to improved regulatory adherence.
• Trained employees on quality management systems and best practices, fostering a culture of excellence within the organization.
• Implemented risk-based approach to quality control, reducing potential hazards and improving overall safety measures.

• Scheduled and managed internal and supplier-based audits to verify compliance with document control procedures.
• Tracked corrective action reports and confirmed closure of corrective action requests to demonstrate adherence to quality standards.
• Collaborated with internal subject matter experts to perform data reconciliations and produce credible results.
• Monitored active and inactive department rosters and updated database to reflect employee additions and deletions.
• Performed data entry tasks and verified that charts and graphs produced accurate representations of data inputs.
• Planned, designed, and scheduled phases for large projects.
• Monitored project performance to identify areas of improvement and make adjustments.
• Coordinated with cross-functional teams to resolve project issues and mitigate risks.
• Provided detailed project status updates to stakeholders and executive management.
• Evaluated suitability of business and technical processes and procedures and recommended improvements to comply with updated operations guidelines.
• Maintained quality system documentation and updated specific documents to reflect new audit or test results.
• Worked with users to maintain accurate quality records and supporting materials to document quality-related activities.
• Generated monthly QMS reports to monitor KPI performance to ensure predetermined quality objectives are met.
• Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
• Archived quality audit reports and generated searchable index to facilitate improved report access.
• Managed and archived quality documentation and participated in internal and external quality audits.
• Collaborated with Research and Development on new product launches, guaranteeing a seamless introduction into the market without compromising on quality standards.
• Wrote and implemented new rework procedures to standardize processes and streamline workflow.
• Devised specifications for processes.
• Increased customer satisfaction through adherence to quality standards and customer requirements.
• Assured regulatory compliance with applicable industry standards by staying abreast of updates or changes in requirements, adjusting organizational policies accordingly when necessary.
• Partnered with sales and marketing teams to ensure customer feedback was utilized for continuous improvement initiatives within the organization.
• Mentored fellow team members on best practices in quality assurance, fostering a culture of continuous learning and growth.
• Equipped and organized facility to comply with company strategy for online and offline quality controls.
• Assured consistent quality of production by implementing and enforcing automated practice systems.
• Established and tracked quality department goals and objectives.
• Improved quality processes for increased efficiency and effectiveness.
• Updated quality control standards, methods, and procedures to meet compliance requirements.
• Enhanced product quality by developing and implementing robust quality management systems.
• Inspected products and worker progress throughout production.
• Advanced overall customer satisfaction by monitoring and addressing quality-related complaints promptly.
• Applied coaching techniques and tools to support managers and team members in improving performance.
• `Evaluated quality problems and performed assessments to identify and resolve issues.
• Recorded, analyzed, and distributed statistical information.
• Generated monthly reports to compare [Type] program performance to predetermined standards.
• Implemented new quality assurance and customer service standards.
• Implemented comprehensive training programs for staff, ensuring consistent understanding and application of established processes across all departments.
• Developed effective inspection plans to ensure proper assessment at each stage during production.
• Managed supplier relationships, ensuring consistent delivery of high-quality raw materials for production.
• Championed root cause analyses to accurately pinpoint areas of improvement within the organization''s processes and procedures.
• Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
• Achieved ISO certification through diligent preparation, documentation, and adherence to international standards of quality management.
• Conducted thorough risk assessments to identify potential issues and develop appropriate mitigation strategies.
• Reduced error rates by conducting regular audits of both internal operations and external suppliers'' facilities.
• Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
• Determined quality department standards, practices, and procedures.
• Calibrated instruments and scales in production area and quality lab.
• Tracked quality issues with external customers, suppliers, and internal plant operations.
• Liaised with HR manager to organize and perform quality standard training for new and existing staff.
• Improved communication channels between departments through routine meetings focused on addressing challenges related to maintaining high levels of product quality.
• Participated in targeted customer audit initiatives and produced required documentation to support verifiable results.
• Optimized inventory control measures with a focus on reducing waste while maintaining adequate stock levels for smooth operations.
• Mentored and encouraged employees to strive for excellence while fostering professional growth.
• Provided observations, took measurements, and performed tests at various stages according to quality control plan.
• Streamlined production processes for increased efficiency and reduced manufacturing defects.
• Reported production malfunctions to managers and production supervisors.
• Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
• Led cross-functional teams in designing and executing process improvement initiatives for better product performance.
• Advised management of quality audit non-compliance issues to facilitate improved audit e rates.
• Monitored staff organization and suggested improvements to daily functionality.
• Specified quality requirements of raw materials with suppliers.
• Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
• Developed and deployed production control plans and created work instructions and procedures.
• Drove cost savings by identifying inefficiencies in processes, proposing and implementing solutions for increased profitability without sacrificing product quality.
• Advised management of quality audit non-compliance issues to facilitate improved audit compliance rates.

• Maintained document control system and updated work instructions, procedures and associated databases.
• Provided assistance with inbound and outbound document processes, document sorting, logging and work order creation.
• Worked with internal staff to process documents and sent for closing.
• Converted documents from one application to another.
• Performed document reproduction, printing documents from electronic sources such as email attachments, PDF files and cloud storage.
• Managed continuous improvement activities while developing and maintaining resulting activities
• Assisted in continuous improvement activities while developing and maintaining resulting documents by implementing
• Identified areas of weakness and recommended or implemented process improvements.

• Maintained document control system and updated work instructions, procedures and associated databases.
• Provided assistance with inbound and outbound document processes, document sorting, logging and work order creation.
• Worked with internal staff to process documents and sent for closing.
• Converted documents from one application to another.

• 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.
• Maintained clean and well-organized production areas to avoid violations or unnecessary work delays due to hazards or inefficient layouts.
• Monitored workflow to improve employee time management and increase productivity.
• Evaluated employee performance and coached and trained to improve weak areas.
• Maintained compliance with company policies, objectives, and communication goals.
• Achieved results by working with staff to meet established targets.
• Mentored newly hired employees on operating equipment and safety and developed training manual to use for reference.
• Enforced rules and regulations outlined in company manual to set forth expectations comprehensibly and consistently.

• Streamlined document control processes by implementing efficient tracking and management systems.
• Enhanced team productivity by providing comprehensive training and support for document control staff.
• Reduced errors in documentation by conducting thorough quality checks before submission or distribution.
• Optimized workflows with the development and implementation of standardized document templates and guidelines.
• Ensured timely completion of projects by maintaining up-to-date schedules, tracking progress, and addressing any issues promptly.
• Improved document accessibility by creating a centralized digital repository for easy retrieval and reference.
• Maintained strict compliance with industry regulations through diligent monitoring of all documentation practices.
• Collaborated closely with cross-functional teams to ensure seamless integration of documentation processes into overall project planning.
• Boosted document security with the implementation of robust access controls and user authentication measures.

• Enhanced team productivity by providing comprehensive training and support for document control staff.
• Streamlined document control processes by implementing efficient tracking and management systems.
• Reduced errors in documentation by conducting thorough quality checks before submission or distribution.
• Optimized workflows with the development and implementation of standardized document templates and guidelines.
• Ensured timely completion of projects by maintaining up-to-date schedules, tracking progress, and addressing any issues promptly.

• Showed patrons where to find library resources and collected equipment, reference pieces, and other items.
• Combined traditional skills ol librarian with instructional technologist and instructional designer to enhance all facets of learning.
• Processed customer fines and educated individual patrons on ways to minimize future charges.
• Mitigated librarian workload by independently managing basic patron requests and locating materials.
• Enhanced library user experience by providing efficient customer service and assistance with various resources.
• Streamlined book circulation process by maintaining an organized and accurate database of materials.
• Assisted patrons in locating materials, enabling them to conduct research more effectively.
• Collaborated with librarians to develop informative and engaging displays to promote library resources.
• Conducted inventory audits for accurate record-keeping and timely identification of missing or damaged items.
• Trained new Library Technicians, ensuring they were familiar with library policies and procedures for optimal performance.
• Managed interlibrary loan requests, facilitating access to resources from other institutions for patrons.
• Ensured a welcoming environment by maintaining clean and orderly spaces within the library.
• Supported community outreach initiatives by participating in local events promoting literacy and education.
• Utilized advanced cataloging techniques for precise organization of library materials, improving overall accessibility for users.
• Processed incoming materials efficiently, expediting their availability for patron use.
• Resolved customer concerns diplomatically, resulting in increased patron satisfaction levels.
• Implemented new shelving strategies that maximized available space without compromising ease of access for patrons.
• Developed resource guides on various topics to assist patrons in their research efforts more effectively.
• Participated in staff meetings, contributing valuable input towards improvement of library services and operations.
• Provided technical support to patrons using computers, printers, and other equipment within the facility.
• Enhanced library user experience by assisting patrons with resource navigation and research inquiries.

• Handled scheduling for executive's calendar and prepared meeting agenda and materials.
• Coordinated and booked airfare, hotel and ground transportation and prepared itinerary to facilitate successful trips.
• Responded to emails and other correspondence to facilitate communication and enhance business processes.
• Answered multi-line phone system, routing calls, delivering messages to staff and greeting visitors.
• Executed record filing system to improve document organization and management.
• Restocked supplies and placed purchase orders to maintain adequate stock levels.
• Received and sorted incoming mail and packages to record, dispatch, or distribute to correct recipient.
• Created and maintained databases to track and record customer data.
• Developed and updated spreadsheets and databases to track, analyze, and report on performance and sales data.
• Scheduled office meetings and client appointments for staff teams.
• Coordinated and scheduled meetings and conference calls to optimize scheduling of senior staff.
• Assisted development and implementation of new administrative procedures.

• Sanitized, restocked, and organized exam rooms and medical equipment.
• Directed patients to exam rooms, fielded questions, and prepared for physician examinations.
• Obtained client medical history, medication information, symptoms, and allergies.
• Performed medical records management, including filing, organizing and scanning documents.
• Called and faxed pharmacies to submit prescriptions and refills.
• Documented vital signs and health history for patients in clinic and hospital environments.
• Collected and documented patient medical information such as blood pressure and weight.
• Identified issues, analyzed information and provided solutions to problems.
• Strengthened communication skills through regular interactions with others.
• Demonstrated respect, friendliness and willingness to help wherever needed.
• Proved successful working within tight deadlines and a fast-paced environment.
• Excellent communication skills, both verbal and written.
• Used critical thinking to break down problems, evaluate solutions and make decisions.
• Cultivated interpersonal skills by building positive relationships with others.
• Worked flexible hours across night, weekend and holiday shifts.
• Organized and detail-oriented with a strong work ethic.
• 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.
• Participated in team projects, demonstrating an ability to work collaboratively and effectively.
• Managed time efficiently in order to complete all tasks within deadlines.
• Passionate about learning and committed to continual improvement.
• Worked well in a team setting, providing support and guidance.
• Self-motivated, with a strong sense of personal responsibility.
• Paid attention to detail while completing assignments.