Field Quality QA Specialist — Real-Time Batch Readiness

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

Job summary

Bristol Myers Squibb is seeking a Senior Field QA Specialist to ensure GMP compliance in manufacturing. You will review MBRs, perform on-the-floor exceptions reviews, and support RTS walkthroughs to confirm clean and ready facilities. The role collaborates with Manufacturing Operations to investigate issues and contribute to SOPs and deviation resolution.

Shift: Monday–Friday, 7:00 AM–3:30 PM. This position is based in Devens, MA, with responsibility for real-time quality assurance and audit

Qualifications

• BS in science/engineering or related field.
• Minimum 4 years QA experience in pharma/medical device.
• Experience reviewing batch records.

Responsibilities

• Quality floor support of complex manufacturing activities.
• Performs batch production record reviews for product release per specs and SOPs.
• Walkthrough GMP areas documenting observations and concerns.
• Provide training on routine quality tasks for new team members.
• Support RTS walkthroughs and readiness inspections per procedures.
• Ensure QA-relevant documentation complies with cGMP and site procedures.

Skills

GMP knowledge

QA experience

Batch record review

Interpersonal skills

Education

Bachelor's degree in science/engineering

Tools

DeltaV

Job description

Bristol Myers Squibb is seeking a Senior Field QA Specialist to ensure GMP compliance in manufacturing. You will review MBRs, perform on-the-floor exceptions reviews, and support RTS walkthroughs to confirm clean and ready facilities. The role collaborates with Manufacturing Operations to investigate issues and contribute to SOPs and deviation resolution.

Shift: Monday–Friday, 7:00 AM–3:30 PM. This position is based in Devens, MA, with responsibility for real-time quality assurance and audit