The QA Specialist I, Document Control is a senior individual contributor and the accountable owner of the GMP Document Control program for the Canton, MA vaccine Drug Substance (DS) manufacturing site.
This role is responsible for the end‐to‐end governance, execution, and continuous improvement of document and records management processes in compliance with US FDA 21 CFR Parts 210, 211, and applicable global regulatory expectations.
The incumbent serves as the site subject matter expert (SME) for the Electronic Document Management System (EDMS) and Good Documentation Practices (GDP), ensuring adherence to ALCOA+ principles across the document lifecycle.
The role partners closely with Global Process Owners (GPOs), site Quality leadership, Manufacturing, MSAT, and other support functions to ensure global standards are effectively implemented at the site, inspection‐ready at all times, and scalable to support commercial vaccine operations.
ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
GMP Document Control Program Ownership Own and independently manage all aspects of the site GMP Document Control program, including governance, procedures, execution, and compliance oversight for controlled documents and GMP records.
Administer and maintain the site EDMS as the primary point of contact, including document lifecycle management, system configuration support, user access control, and alignment with global processes.
Ensure implementation and continuous adherence to Good Documentation Practices (GDP) and ALCOA+ principles across all GMP documentation.
Controlled Documents and Records Management Manage issuance, review coordination, approval workflows, effective dating, archiving, retrieval, and retention of controlled GMP documents, including SOPs, master batch records, forms, templates, and logbooks.
Ensure secure on‐site and off‐site archiving, chain of custody, traceability, and retrieval of GMP records in accordance with regulatory and internal retention requirements.
Issue and control GMP batch documentation and executed logbooks in compliance with site procedures.
Quality System and Compliance Support Author, review, and manage document control–related deviations, change controls, CAPAs, and effectiveness checks; provide data‐driven recommendations to improve system performance.
Develop, monitor, and report key performance indicators (KPIs) for document control processes to support Quality Management Review (QMR) and continuous improvement.
Training, Stakeholder Engagement, and Global Alignment Provide expert guidance, training, and coaching to document authors and approvers on document standards, EDMS usage, and GDP expectations.
Partner with Global Process Owners (GPOs) to deploy and sustain global document and records management standards, ensuring local procedures remain aligned with enterprise systems and regulatory expectations.
Inspection Readiness and Regulatory Support Lead document control support during regulatory inspections, internal audits, and customer audits, including direct interaction with inspectors as the site SME.
Coordinate and lead document control responses to audit observations, ensuring timely, accurate, and compliant documentation.
Continuous Improvement Identify, lead, and implement continuous improvement initiatives to enhance document lifecycle efficiency, data integrity, inspection readiness, and user experience.
Apply risk‐based thinking to prioritize improvements and ensure a state of ongoing compliance.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties.
Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company’s vaccination policies where job-related and consistent with applicable law.
We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.
Education and Experience Bachelor’s degree in Life Sciences, Quality, Information Management, or a related discipline; or equivalent education and experience.
Minimum of 7 years of progressively responsible experience in GMP Quality Assurance, with at least 4 years focused on Document Control and records management in an FDA‐regulated pharmaceutical or biotechnology environment.
Demonstrated experience supporting commercial vaccine, biologics, or drug substance manufacturing operations strongly preferred.
Technical and Regulatory Expertise Expert knowledge of US FDA cGMP requirements, GDP/GDocP, data integrity, and ALCOA+ principles.
Advanced hands‐on experience with Electronic Document Management Systems (e.g., Veeva Vault or equivalent), including system administration support and user training.
Strong working knowledge of change management, deviation management, CAPA, and inspection readiness practices.
Core Competencies Ability to operate independently with minimal supervision in a highly regulated environment while exercising sound judgment and decision‐making authority.
Excellent written and verbal communication skills, with the ability to effectively influence and partner across all organizational levels, including global stakeholders and regulators.
Strong organizational, analytical, and problem‐solving skills with a continuous improvement mindset.
