Quality Assurance Analyst

University of California, Irvine is hiring a Quality Assurance Analyst to support the Quality Assurance Unit within the School of Medicine's cGMP Facility. The role involves performing quality assurance activities such as batch record review, product disposition, and compliance evaluation to ensure the manufacturing of cellular and gene therapy products meets regulatory standards.

• Support GMP manufacturing operations and process development by managing product labeling, batch records, and inventory.
• Evaluate compliance of manufacturing records from contract manufacturing organizations to ensure accuracy and completeness.
• Develop, maintain, and enforce quality plans and standards for inspections and accreditation activities.
• Collaborate with stakeholders to perform risk assessments and support drug development processes.
• Ensure compliance with quality systems, internal SOPs, deviations, CAPAs, change controls, and regulatory requirements.
• Requires knowledge of cGMP regulations, FDA and EMA guidelines, and experience preparing for regulatory inspections.
• Proficiency with computer software for document management, electronic deviation systems, and technical report writing.
• Bachelor’s degree in Nursing or relevant healthcare field with at least one year of experience in toxicology, chemistry, or biologics regulation.
• Salary range from USD $97,000 to $182,200 per year.
• Experience preferred in clinical laboratory setup and conducting internal audits.