Quality Assurance Specialist III - Brea, CA

Quality Assurance Specialist

The Quality Assurance Specialist provides real-time quality oversight and support during manufacturing operations to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal procedures. This position serves as the primary quality representative on the manufacturing floor and is responsible for quality decision-making, batch record review, line clearance verification, aseptic processing oversight, and support of investigations and quality systems.

Essential Duties and Responsibilities:

• Provide QA oversight during manufacturing and warehouse operations.
• Gown in support to routinely work at controlled rooms; perform aseptic processing audits; perform quality oversights of facilities, process, and personnel; approve quality deviations.
• Perform line clearance activities before manufacturing and packaging operations.
• Perform QA review and release of raw materials, components, and other GMP materials in accordance with approved procedures.
• Conduct routine facility, process, and personnel GMP observations.
• Monitor production schedules and ensure adequate QA support coverage.
• Manage reserve sample inventory, storage, reconciliation, and retention activities.
• Review and approve technical documents including protocol/report.
• Author/Review/approves IQ/OQ/PQ of instruments Protocols and Reports, calibration reports, maintenance reports, OOTN, discrepancy reports, CAPAs, and CCRs as needed.
• Review/approves batch records, logbooks and other related cGMP documents.
• Perform any other tasks/duties as assigned by management.