QA Batch Record Reviewer

Job Title: Quality Assurance Batch Record Reviewer I
Location: Andover, MA
Hours/Schedule: Monday–Friday, 8 am to 5 pm
Type: Contract

The Quality Assurance Batch Record Reviewer I is an entry-level, floor-based QA role supporting manufacturing operations through real-time batch record review and GMP oversight. This position works directly in production suites to ensure compliance during active manufacturing and to support quality activities as they occur.

• Perform real-time batch record review during manufacturing operations.

• Conduct GMP compliance walkthroughs within production suites.

• Partner with manufacturing operators and cross-functional teams to identify and address compliance issues in real time.

• Provide on-the-floor QA support during active production rather than post-production, desk-based review.

• Document findings and support resolution of batch record and GMP-related issues.

• Bachelor’s degree in a scientific discipline (Biology or Chemistry preferred; related science fields acceptable).

• 0–2 years of relevant experience; entry-level candidates encouraged to apply.

• Hands-on experience or demonstrated knowledge of GMP requirements.

• Exposure to batch record review processes (experience strongly preferred).

• Previous Quality Assurance experience in a manufacturing environment.

• Familiarity with pharmaceutical or biotechnology manufacturing operations.

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.