Quality Assurance Analyst

🇺🇸 Irvine, California 🕑 Full-Time 💰 $102K - $191K 💻 Quality Assurance 🗓️ August 26th, 2026

Edtech.com's Summary

University of California, Irvine is hiring a Quality Assurance Analyst. The analyst will support GMP manufacturing operations and process development in the School of Medicine's GMP Facility by performing quality assurance activities, reviewing batch records, managing product inventories, and ensuring compliance with regulatory standards.

Highlights

Support Quality Assurance Unit in GMP manufacturing operations.
Perform product label issuance, batch record review, and inventory management.
Coordinate and prepare documentation for Investigational New Drug (IND) submissions.
Evaluate compliance of manufacturing records and conduct risk assessments.
Ensure adherence to cGMP regulations and FDA/EMA guidelines.
Use electronic systems for deviations, CAPAs, and change control management.
Conduct internal audits and prepare for regulatory inspections.
Required qualifications include a Bachelor's degree in Nursing or related field and at least 1 year of relevant experience.
Preferred experience includes 2 years in clinical laboratory setup.
Salary range: USD $101,852.64 to $191,302.56 per year.