GMP QA Specialist — Manufacturing & Documentation

Bristol-Myers Squibb Co; Harvard (MA); On-site; USD 82,000 - 99,000; Full time

Benefits offered by this job

Flexible Time Off (US)

11 paid company holidays

Vacation time: 160 hours

Volunteer days

Global Shutdown between Christmas and/

Job summary

Bristol Myers Squibb is seeking a Quality professional to provide oversight for in-process materials and manufactured products, ensuring adherence to cGMP and regulatory standards. Responsibilities include reviewing documents, supporting investigation records, and ensuring QA compliance across manufacturing operations.

The role covers routine batch review, QA floor support, and participation in inspections as needed, with emphasis on documentation integrity and process improvements in Devens, MA.

Qualifications

• Knowledge of biotech bulk and finished product manufacturing and analytical testing is desirable.
• Familiarity with US and EU cGMP regulations and guidance.
• Working knowledge of MS-Word and Excel is required.
• Knowledge of electronic or paper batch record systems, DeltaV, and other electronic systems is desirable.

Responsibilities

• Quality floor support for minor and routine manufacturing activities.
• Performs routine manufacturing batch production record review for media/buffer/cryo in support of product release in accordance with specifications and SOPs.
• Perform walkthroughs of GMP areas documenting observations and areas of concern.
• Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
• Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.
• May support the Quality review of manufacturing deviations.
• May support release of incoming or manufactured products.
• Routine QA Floor Support Activities, including but not limited to alarm review, logbook review, etc.
• Other duties as assigned

Skills

Biotech manufacturing knowledge

cGMP regulations

MS Word & Excel

Education

B.S. in science, engineering, biochemistry or related discipline

2 years relevant experience in a regulated environment

Tools

DeltaV

Electronic batch record systems

Job description

Bristol Myers Squibb is seeking a Quality professional to provide oversight for in-process materials and manufactured products, ensuring adherence to cGMP and regulatory standards. Responsibilities include reviewing documents, supporting investigation records, and ensuring QA compliance across manufacturing operations.

The role covers routine batch review, QA floor support, and participation in inspections as needed, with emphasis on documentation integrity and process improvements in Devens, MA.