Field Quality Specialist – GMP Compliance

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

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Specialist, Field Quality to provide quality assurance support for operations, in-process materials, and manufactured products, ensuring compliance with cGMP and regulatory standards. You will perform batch record reviews, support investigations and deviations, and help prepare for inspections, with emphasis on QA floor activities and documentation integrity.

Candidates should have a BS in science or related field and 2 years regulated-environment

Qualifications

• Knowledge of biotech bulk and finished product manufacturing and analytical testing 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 applicable to laboratory test result generation, inventory management, investigations and equipment tracking, and maintenance 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

DeltaV / electronic systems

Education

BS in science or related

2 years regulated environment experience

Tools

DeltaV

Job description

Bristol Myers Squibb in Devens, MA is seeking a Specialist, Field Quality to provide quality assurance support for operations, in-process materials, and manufactured products, ensuring compliance with cGMP and regulatory standards. You will perform batch record reviews, support investigations and deviations, and help prepare for inspections, with emphasis on QA floor activities and documentation integrity.

Candidates should have a BS in science or related field and 2 years regulated-environment