Specialist I, Document Control at Emergent BioSolutions in Canton, MA

Job description

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY 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 a