GMP Document Control Lead - Inspection Ready

Emergent Biosolutions; Canton (MA); On-site; USD 129,000 - 156,000; Full time

Job summary

Emergent BioSolutions in Canton, MA, seeks a QA Specialist I, Document Control to own the GMP document control program for the vaccine Drug Substance site. You will govern controlled documents, ensure GDP/ALCOA+ compliance, and serve as the EDMS SME to support inspection readiness and regulatory alignment.

You will lead doc control workflows, archiving, deviations, CAPAs, and KPIs to drive continuous improvement and robust data integrity across the site.

Qualifications

• 7+ years of GMP Quality Assurance experience with at least 4 years focused on Document Control and records management in FDA-regulated environment.
• Strong knowledge of US FDA cGMP, GDP/GDocP, data integrity, and ALCOA+ principles.
• Experience with EDMS and system administration support; ability to train users.

Responsibilities

• Own and manage the site GMP Document Control program including governance and compliance oversight.
• Administer and maintain the EDMS as primary contact with lifecycle management, access control, and global alignment.
• Lead document control deviations, change controls, CAPAs, and effectiveness checks; monitor KPIs.

Skills

GMP knowledge

Data integrity

Documentation practices

Regulatory knowledge

Education

Bachelor's degree in Life Sciences or related

Tools

Veeva Vault

Job description

Emergent BioSolutions in Canton, MA, seeks a QA Specialist I, Document Control to own the GMP document control program for the vaccine Drug Substance site. You will govern controlled documents, ensure GDP/ALCOA+ compliance, and serve as the EDMS SME to support inspection readiness and regulatory alignment.

You will lead doc control workflows, archiving, deviations, CAPAs, and KPIs to drive continuous improvement and robust data integrity across the site.