Specialist I, Document Control

Role: Senior individual contributor owning GMP Document Control at a vaccine manufacturing site, ensuring compliance with FDA and global standards. Responsibilities: manage end-to-end document and record governance, oversee EDMS, maintain Good Documentation Practices (GDP) and ALCOA+ principles, handle controlled documents and GMP records, support inspection readiness, and lead continuous improvement initiatives. Partner with global stakeholders, provide training, and support regulatory audits and responses. Qualifications: Bachelor's in Life Sciences, Quality, or related field; 7+ years in GMP Quality Assurance with 4+ years in Document Control within FDA-regulated pharma/biotech environments; expertise in US FDA cGMP, GDP/GDocP, data integrity, EDMS systems (e.g., Veeva Vault); strong communication and organizational skills. Preferred: professional certifications such as CRM, DMCP, or ASQ. HighValue: vaccine biologics manufacturing, GMP compliance, electronic document management, FDA-regulated environment, inspection readiness. WorkSetup: onsite in Canton, MA; no travel specified.