GMP Document Control Specialist

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

Job summary

Emergent BioSolutions in Canton, MA is seeking a QA Specialist I, Document Control to own the GMP Document Control program at the Canton site and ensure GDP/ALCOA+ compliance across documents and records.

You will manage the EDMS, support change controls, deviations, CAPAs, and prepare for inspections with global partners, delivering data-driven improvements and inspection readiness at all times.

Qualifications

• Bachelor’s degree in Life Sciences, Quality, Information Management, or related field.
• 7 years in GMP QA with at least 4 years in document control and records management.
• Experience supporting vaccine/biotech manufacturing preferred.

Responsibilities

• Own and manage the site GMP Document Control program, including governance, procedures, and compliance oversight for controlled documents and GMP records.
• Administer and maintain the EDMS as primary contact, including lifecycle management, access control, and alignment with global processes.
• Ensure GDP and ALCOA+ adherence across GMP documentation.
• Author, review, and manage deviations, change controls, CAPAs, and effectiveness checks; provide data-driven improvements.
• Lead inspections support and regulatory readiness, coordinating responses to audit observations and aligning with global standards.

Skills

GMP QA experience

Document control

Education

Bachelor’s degree in Life Sciences/Quality/Information Management

Tools

Veeva Vault

Job description

Emergent BioSolutions in Canton, MA is seeking a QA Specialist I, Document Control to own the GMP Document Control program at the Canton site and ensure GDP/ALCOA+ compliance across documents and records.

You will manage the EDMS, support change controls, deviations, CAPAs, and prepare for inspections with global partners, delivering data-driven improvements and inspection readiness at all times.