Quality Assurance Specialist III

About the role

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.

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/approve IQ/OQ/PQ of instruments protocols and reports, calibration reports, maintenance reports, OOTN, discrepancy reports, CAPAs, and CCRs as needed.
• Review/approve batch records, logbooks and other related cGMP documents.
• Perform any other tasks/duties as assigned by management.

Requirements

• Bachelor’s degree in chemistry or biology; or equivalent combination of education and experience.
• 8+ years of experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA.
• Broad knowledge of scientific theories, instrumentation, and analytical techniques.
• Thorough knowledge of GMPs and pharmaceutical products.
• Working knowledge of all phases of pharmaceutical manufacturing and laboratory operations.
• Expertise with writing, editing, or reviewing documents such as SOPs, work instructions, batch records, guidelines, etc.
• Experience in providing high quality deliverables while meeting business needs.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves; PPE and respirators are essential