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

Job description

Your Role: The role is responsible for driving and building quality assurance in a GMP multi-product facility. The Senior QA Specialist II provides quality assurance oversight for GMP manufacturing operations to ensure compliance with regulatory requirements, internal procedures, and quality standards. This role supports QA on-the-floor activities, batch record review, and quality system processes during swing shift operations, ensuring manufacturing activities meet cGMP, FDA, and company quality requirements. This position is also responsible for, reviewing and approving Environmental Monitoring and, lot disposition, line clearance and inspecting, reviewing, and dispositioning raw materials, reagents and components. This position represents Quality at cross functional team meetings and client meetings. This position will also assist the Quality Engineering team with review and approval of validation and facilities protocols, reports and documentation. Requirements: Skills: - Provide QA on-the-floor oversight during swing shift manufacturing operations, ensuring compliance with approved procedures, batch records, and regulatory requirements. - Support real-time manufacturing activi...