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Manufacturing Quality Assurance (MQA) Specialist - 2nd Shift
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- The Manufacturing Quality Assurance (MQA) Specialist - 2nd Shift is responsible for performing Root Cause Analysis (RCA) to determine the most likely cause of Quality Events (i.e., manufacturing deviations, environmental excursions.
- Implement appropriate Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas.
- Oversees all operational and pharmacy areas ensuring adherence to cGMP and Standard Operating Procedures
- Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
- Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
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