Quality Assurance Specialist I *PC 602

This position is primarily responsible for providing Quality Assurance support for manufacturing operations to ensure compliance with cGMP, internal procedures, and regulatory requirements. This role performs on-the-floor QA oversight, batch record review, product disposition activities, and supports the investigation and review of deviations and other quality events.

Essential Duties and Responsibilities:

• 2nd shift OTF support or weekends.
• Provide QA on-the-floor support to manufacturing, packaging, and warehouse operations to ensure compliance with cGMP and site procedures.
• Perform real-time line checks, AQL inspections, and verification of critical steps in production processes.
• Review executed batch records, logbooks, and other production documentation for completeness, accuracy, and compliance prior to disposition.
• Assist in product disposition by preparing QA summaries, verifying data integrity, and ensuring all ...