John Follett
Plymouth,CA
Summary
Results-driven Quality Assurance Lead with over twenty years of experience in upholding and enhancing Quality Management System (QMS) standards. Expertise in conducting thorough QA audits and extracting critical data to create comprehensive analytical reports that drive informed decision-making. Proven track record of maintaining high-quality thresholds while overseeing the development and review of complex technical frameworks. Skilled in issuing actionable recommendations that address key criteria and challenges, ensuring continuous improvement in the effectiveness of quality management systems.
Overview
17
17
years of professional experience
Work History
Pet Care Associate
Just Around the Corner, Inc.
Plymouth, MA
04.2025 - Current
- Provided reliable, compassionate care for dogs, cats, and other household pets, including feeding, walking, administering medication, and offering companionship.
- Maintained a consistent schedule of daily pet care visits, ensuring pets' physical and emotional well-being while owners are away.
- Built strong, trusting relationships with pet owners through clear communication, regular updates, and attention to each pet's specific needs.
- Managed scheduling and client communication, demonstrating strong time management and customer service skills.
- Experienced with a wide range of breeds, temperaments, and special needs, including senior pets and those with behavioral challenges.
Owner & Operator
Independent 3D Printing & Laser Craft Business
Plymouth, MA
04.2024 - Current
- Founded and managed a small business specializing in 3D printed products and laser-cut crafts.
- Produced a wide range of items including home decor, toys, novelties, and personalized gifts using advanced 3D modeling software and laser cutting tools.
- Oversaw all aspects of business operations including client relations, manufacturing, quality control, marketing, and order fulfillment.
- Maintained and calibrated 3D printers and laser cutting equipment to ensure high-quality, precise output.
Manager, QA Document Control
Emergent BioSolutions
Canton, MA
09.2021 - 11.2023
- Managed daily operations for the Document Control department to ensure the needs of internal customers are met with a high degree of satisfaction.
- Managed development needs of Document Control staff to support the evolving Quality Systems at the site.
- Led cross-functional teams to enhance operational efficiency and improve project outcomes.
- Developed and implemented strategic plans to align departmental goals with organizational objectives.
- Responsible for the documentation Quality Management System in Canton (from record generation/issuance to archival and retention).
- Managed the Electronic Document Management System (EDMS), Veeva Vault, and lead process improvement by developing and implementing plans to evolve internal systems for greater efficiency and quality.
- Provided oversight for training of campus personnel relating to execution and interactions in the EDMS and QMS, Veeva Vault.
- Participated in the planning, coordination, development, training, and implementation of triennial upgrades and additional module deployment for the EDMS and QMS, Veeva Vault.
- Provided monthly reports on departmental metrics, highlighting areas of concern to senior management, and proposed/implemented improvements.
- Supported completion of department operational tasks related to record and document issuance, processing, and archival related to GMP production.
- Provided support during regulatory and internal inspection activities managing and coordinating the back-room inspection activities.
- Ensured documentation practices are consistent and complementary (GDP) following proper ALCOA+ principles.
- Authored and executed tasks for document revisions, deviation investigations, CAPAs, and change controls related to Document Control processes.
- Oversaw daily operations, ensuring efficiency and compliance with company standards.
- Developed and implemented strategic initiatives to enhance team performance and productivity.
- Mentored staff on best practices, fostering a culture of continuous improvement and collaboration.
- Analyzed operational workflows, identifying areas for optimization and process enhancement.
Analyst III, QA Document Control
Emergent BioSolutions
Canton, MA
08.2020 - 09.2021
- Provided support for staff with technical questions related to Document Control quality systems and maintained a high degree of customer satisfaction.
- Supported completion of department operational tasks related to record and document issuance, processing, and archival related to GMP production.
- Processed access requests, performed user analysis, and made recommendations for relevant computer systems (QMS and EDMS, Veeva Vault).
- Participated in the planning, coordination, development, training, and implementation of triennial upgrades and additional module deployment for the EDMS and QMS, Veeva Vault.
- Developed, scheduled, and conducted site training for supported quality systems (QMS and EDMS, Veeva Vault).
- Authored and executed tasks for document revisions, non-conformances, CAPAs, and change controls related to Document Control quality system.
- Provided support during regulatory and internal inspection activities.
- Compiled and reported performance metrics for Document Control quality systems and provided recommendations to improve performance.
- Represented the Document Control department in a review and decision-making capacity on site projects.
- Analyzed data trends to support decision-making and strategic planning initiatives.
- Developed comprehensive reports on performance metrics for senior management review.
- Collaborated with cross-functional teams to identify process improvement opportunities.
- Led projects aimed at optimizing operational workflows and resource allocation.
- Presented findings and recommendations to stakeholders, influencing key business strategies.
- Collaborated with cross-functional teams to identify opportunities for process improvement and increased efficiency.
- Improved internal knowledge sharing by developing comprehensive documentation outlining standard operating procedures for various tasks.
Analyst II, QA Document Control
Emergent BioSolutions
Canton, MA
10.2017 - 08.2018
- Provided support for staff with technical questions related to Document Control quality systems and maintained a high degree of customer satisfaction.
- Supported completion of department operational tasks related to record and document issuance, processing, and archival related to GMP production.
- Participated in the planning, development, training, and implementation of upgrades and additional feature activation for the EDMS, Veeva Vault.
- Conducted training for the EDMS, Veeva Vault, and revised training content as needed along with distribution materials for end-user reference.
- Authored and executed tasks for document revisions, non-conformances, CAPAs, and change controls related to Document Control quality system.
- Provided support during regulatory and internal inspection activities.
- Compiled and reported performance metrics for Document Control quality systems.
- Analyzed complex data sets to identify trends and inform strategic decisions.
- Developed and implemented analytical models to enhance operational efficiency.
QA Documentation Control Professional
Sanofi Pasteur
Canton, MA
12.2016 - 10.2017
- Processed controlled GMP documentation in support of production activities.
- Managed document deliverables.
- Formatted and edited drafts of quality documents to ensure compliance with regulatory requirements.
- Provided support during regulatory and internal inspection activities.
- Maintained databases and filing systems for documentation, archives, logbooks, and off-site storage.
- 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.
- 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.
QA Documentation Specialist II
Sanofi Pasteur
Canton, MA
09.2016 - 12.2016
- Contractor from Kaztronix, LLC
- Developed and maintained comprehensive documentation for internal processes and procedures.
- Collaborated with cross-functional teams to ensure accurate and efficient information transfer.
- Provided support during regulatory and internal inspection activities.
- Developed and maintained comprehensive documentation for regulatory submissions and compliance processes.
- Streamlined document management systems to enhance retrieval efficiency and version control accuracy.
- Collaborated with cross-functional teams to ensure alignment on documentation standards and quality assurance protocols.
- Reviewed and edited technical documents for clarity, consistency, and adherence to industry regulations.
External Quality QA Specialist II – Contractor from Apollo Pros Staffing
Genentech
Cambridge, MA
04.2013 - 04.2016
- Managed all activities to support the release of commercial product; including but not limited to; uploading and approval of External Manufacturing documents into document control system, batch record review, and QMS documentation acceptance (exception reports, investigations, CAPA plans, etc.).
- Developed/maintained quality risk management plans; utilized risk management tools to identify and mitigate cGMP quality and compliance risks; ensured CMO sites are in a state of continuous inspection readiness.
- Collaborated with cross-functional teams to identify, document, and resolve defects in products.
- Led root cause analysis efforts to address recurring issues, driving process refinements.
- Ensured compliance with industry standards and regulations through diligent adherence to established QA procedures and guidelines.
Quality Assurance Compliance Associate – Contractor from Aerotek Scientific
Exemplar Pharmaceuticals
Fall River, MA
01.2013 - 03.2013
- Reviewed manufacturing product batch records.
- Drafted and coordinated the review and revision of procedures, specifications (Raw Material and Finished Goods), and forms.
- Provided support during regulatory and internal inspection activities.
Quality Assurance Associate – Product Quality
Momenta Pharmaceuticals
Cambridge, MA
01.2012 - 12.2012
- Reviewed manufacturing product batch records and testing from internal sources as well as CMO and CTO vendors.
- Drafted and coordinated the review and revision of procedures, specifications (Raw Material and Finished Goods), and forms.
- Assisted in compiling and reviewing regulatory filing documents.
- Assisted in the disposition of commercial products.
- Reviewed, assessed, and approved product documentation (exception reports, investigations, CAPA plans, etc.).
- Reviewed and approved product related protocols and reports.
Quality Assurance Associate – Compliance
Momenta Pharmaceuticals
Cambridge, MA
06.2009 - 01.2011
- Performed production and quality control audits to evaluate inspection readiness.
- Ensured compliance with in-house and/or external specifications and standards.
- Conducted vendor (CMO and CTO) evaluation audits to determine inspection readiness qualifications.
- Reviewed, assessed and approved excursions and CAPA reports.
- Provided support during regulatory and internal inspection activities.
- Assisted in the validation and implementation of an electronic document management system.
Education
Bachelor of Science - Biology
University of Massachusetts Dartmouth
North Dartmouth, MA05.2003
Skills
- Strong attention to detail
- Computer skills
- Customer service and assistance
- Autonomous project execution
- Ability to manage time and complete deliverables
- Dependable and responsible
- Clear written communication
- Proficient in learning digital tools
- Prioritization of personal and professional commitments
- Skilled in utilizing electronic data management tools
- Electronic Document Management Systems (ie, Veeva Vault, NextDocs, MasterControl)
- Workflow Automation software (ie, StartingPoint, Mondaycom)
- Skilled in utilizing Microsoft Office applications effectively
- Experience in FDA regulated environments
- Documentation Specialist (ie, Grammar, Punctuation, Citations)
- Strategic project oversight
- Strong technical computer skills
- Strategic team guidance
- Collaborative decision-making
- Effective problem resolution
- Quality management system compliance
- Quality management system expertise
- Quality management system implementation
- Internal auditing
- Compliance monitoring
- Corrective actions
- Quality processes
- Document management
- SOP development
- Continuous improvement
- Quality training
- Quality metrics
- Failure mode and effects analysis
- Friendly, positive attitude
- Teamwork and collaboration
- Problem-solving
- Attention to detail
Leadership Activities
Boy Scouts of America 1989-1996 (Troop 6 - Eagle Scout), 2024-Present (Troop 51 - Committee member) Sigma Tau Gamma Social Fraternity 1998-2003 (Community Service award recipient) University of Massachusetts - Dartmouth - Student Senate 1999-2002
Timeline
Pet Care Associate
Just Around the Corner, Inc.
04.2025 - Current
Owner & Operator
Independent 3D Printing & Laser Craft Business
04.2024 - Current
Manager, QA Document Control
Emergent BioSolutions
09.2021 - 11.2023
Analyst III, QA Document Control
Emergent BioSolutions
08.2020 - 09.2021
Analyst II, QA Document Control
Emergent BioSolutions
10.2017 - 08.2018
QA Documentation Control Professional
Sanofi Pasteur
12.2016 - 10.2017
QA Documentation Specialist II
Sanofi Pasteur
09.2016 - 12.2016
External Quality QA Specialist II – Contractor from Apollo Pros Staffing
Genentech
04.2013 - 04.2016
Quality Assurance Compliance Associate – Contractor from Aerotek Scientific
Exemplar Pharmaceuticals
01.2013 - 03.2013
Quality Assurance Associate – Product Quality
Momenta Pharmaceuticals
01.2012 - 12.2012
Quality Assurance Associate – Compliance
Momenta Pharmaceuticals
06.2009 - 01.2011
Bachelor of Science - Biology
University of Massachusetts Dartmouth