GMP QA Specialist - Biotech Contract (Lexington)

ACTalent; Lexington (MA); On-site; USD 83,000 - 96,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Life Insurance

Disability coverage

Health Spending Account (HSA)

Time Off (PTO)

Job summary

Actalent is seeking a 12-month contract professional to oversee internal quality operations and external CDMOs/CTLs in Lexington, MA. The role requires reviewing GMP docs, batch records, and release activities, with collaboration across QA, RA, and CMC teams to ensure timely approvals.

Applicants should have a 4+ year background in FDA-regulated pharma/biotech, with GMP manufacturing and analytical development experience, and preferred Biologics/Cell & Gene Therapy exposure.

Qualifications

• Bachelors in a scientific discipline with 4+ years of experience in the FDA regulated pharmaceutical/biotech industry with GMP manufacturing operations, analytical development and quality.
• Experience in Biologics and Combination Products (Cell and Gene Therapy, monoclonal antibodies) is preferred.
• Experience with review of GMP manufacturing records (Master/Executed batch records, change controls, deviations, investigations) associated with clinical programs.
• Hands-on experience with laboratory testing and method validation.

Responsibilities

• Oversee internal quality operations and external service providers (CDMOs/CTLs).
• Review and approve GMP documentation and master/executed batch records and packaging records.
• Perform GMP raw material release activities and review related data.
• Collaborate with QA, RA, CMC teams to support timely review and approval of documents.
• Support batch disposition activities and data uploads in quality systems.

Skills

Biologics experience

GMP documentation review

Lab testing & method validation

Education

Bachelor's in a scientific discipline

Job description

Actalent is seeking a 12-month contract professional to oversee internal quality operations and external CDMOs/CTLs in Lexington, MA. The role requires reviewing GMP docs, batch records, and release activities, with collaboration across QA, RA, and CMC teams to ensure timely approvals.

Applicants should have a 4+ year background in FDA-regulated pharma/biotech, with GMP manufacturing and analytical development experience, and preferred Biologics/Cell & Gene Therapy exposure.