Senior Field QA Specialist — Real-Time GMP Operations

Bristol-Myers Squibb Company; Harvard (MA); On-site; USD 90,000 - 108,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Comprehensive benefits

Job summary

Bristol Myers Squibb is seeking a Senior Field QA Specialist to ensure GMP compliance and real-time quality oversight in day-to-day manufacturing operations at the Devens facility. You will review MBRs, perform on-the-floor exception reviews, and support RTS walkthroughs to confirm clean, calibrated equipment ready for production.

The role collaborates with Manufacturing Operations to investigate issues, author quality SOPs, and support audit readiness while maintaining regulatory and internal

Qualifications

• Bachelor's degree in science, engineering, biochemistry or related discipline preferred.
• 4 years of Quality Assurance experience in pharmaceutical/medical device industry.
• Experience with batch record review and GMP procedures.

Responsibilities

• Quality floor support for complex manufacturing activities.
• Review Manufacturing Batch Records for product release.
• Conduct GMP area walkthroughs and document observations.
• Support RTS walkthroughs and inspection readiness.
• Ensure documentation compliance with cGMP and site procedures.

Skills

Quality assurance

GMP compliance

Batch record review

DeltaV

Education

Bachelor's degree in science or related discipline

Tools

DeltaV

Job description

Bristol Myers Squibb is seeking a Senior Field QA Specialist to ensure GMP compliance and real-time quality oversight in day-to-day manufacturing operations at the Devens facility. You will review MBRs, perform on-the-floor exception reviews, and support RTS walkthroughs to confirm clean, calibrated equipment ready for production.

The role collaborates with Manufacturing Operations to investigate issues, author quality SOPs, and support audit readiness while maintaining regulatory and internal