Quality Assurance Specialist III Brea, CA
Job Summary
Unless specifically stated otherwise this role isOn-Site at the location detailed in the job post.
Nature and Scope
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
Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.
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.
Required Experience:
IC
About Company
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