Senior Specialist, Field Quality QA Operations
$89.53k - $108.49kBristol Myers Squibb
Senior Specialist responsible for quality oversight and GMP compliance in manufacturing operations at a biopharmaceutical facility. Duties include batch record review, facility walkthroughs, return-to-service inspections, deviation investigation, and SOP authoring to maintain regulatory standards and operational readiness.
Responsibilities
- Review manufacturing batch records to support product release per specifications and procedures
- Conduct GMP area walkthroughs and document observations and compliance concerns
- Perform return-to-service and manufacturing readiness walkthroughs to confirm cleanliness and equipment calibration
- Support investigation and resolution of manufacturing issues with Operations teams
- Author and revise quality standard operating procedures and train team members on quality tasks
Requirements
- Bachelor's degree in science, engineering, biochemistry, or related discipline
- 4 years of Quality Assurance experience in pharmaceutical or medical device industry
- Batch record review experience
- Knowledge of US and EU cGMP regulations and guidance
- Knowledge of biotech bulk and finished product manufacturing and analytical testing
- Familiarity with electronic batch record systems and manufacturing software such as DeltaV
Compensation: $89,530–$108,490 base
Vacancy posted 1 day ago
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