• Perform Quality Assurance review and approval of GMP documents, including master documents, executed production records, deviations, investigations, CAPAs, change controls, and controlled documents.
• Provide QA support and oversight for Cell Therapy manufacturing operations to ensure compliance with cGMP requirements and site procedures.
• Conduct QA walkthroughs and on-the-floor quality oversight activities; partner with manufacturing and support groups to identify, investigate, and resolve operational issues.
• Support deviation management, CAPA development, investigation activities, and change control processes as either record owner or QA approver.
• Review and approve GMP documentation generated by Manufacturing, QC, Material Management, Facilities & Engineering, and other supporting departments.
• Perform material release and lot disposition activities in accordance with approved procedures and quality requirements.
• Represent Quality Assurance in internal and external client meetings to ensure quality expectations and regulatory requirements are met.
• Track and manage quality system records to support timely closure and compliance objectives.
• Support internal audits, customer audits, regulatory inspections, and inspection readiness initiatives.
• Provide QA support regarding aseptic manufacturing activities, including gowning, cleanroom operations, and aseptic processing requirements as needed.
• Collaborate cross-functionally with Manufacturing, QC, and Quality Systems teams to drive compliance, process improvements, and operational excellence.
• Perform other duties as assigned.