Senior Quality Assurance Specialist I (Swing Shift) *PC 1606

Job description

Your Role: This position is primarily responsible to supports QA on-the-floor manufacturing activities, batch record review, and quality system processes to ensure operations are conducted in accordance with current Good Manufacturing Practices (cGMP). The position requires the ability to support swing shift manufacturing operations and occasional weekend work. Requirements: Skills: - Provide QA on-the-floor oversight during swing shift GMP manufacturing operations, ensuring adherence to approved procedures, batch records, and regulatory requirements. - Perform review of batch production records, logbooks, and supporting documentation to ensure completeness, accuracy, and compliance prior to QA approval. - Support real-time manufacturing activities, including line clearance verification, material verification, equipment status checks, and monitoring of critical process steps. - Author, review, and revise relevant documentation, such as SOPs, Policies and Standards related to GMP compliance requirements. - Identify and report quality issues, deviations, and compliance risks during manufacturing operations. - Participate in deviation investigations, assist with root cause analysis, a...