Quality Assurance Analyst

🇺🇸 Irvine, CA 🕑 Full-Time 💰 $97K - $182K 💻 Quality Assurance 🗓️ June 28th, 2026

Clari Rive

Edtech.com's Summary

University of California, Irvine is hiring a Quality Assurance Analyst to support its School of Medicine's cGMP manufacturing facility. The role involves performing quality assurance activities such as product label issuance, batch record review, compliance evaluation, and supporting regulatory submissions to ensure adherence to GMP standards and regulatory requirements.

Highlights

Support Quality Assurance Unit in GMP manufacturing operations and process development.
Perform product label issuance, batch record issuance and review, starting material receipt, product disposition, and inventory management.
Coordinate and prepare Investigational New Drug (IND) submissions and participate in regulatory inspections and audits.
Review development and qualification protocols and enforce quality plans and compliance activities.
Require deep understanding of cGMP regulations and FDA/EMA guidelines.
Proficiency with electronic systems to manage deviations, CAPAs, and change controls.
Bachelor's degree in Nursing or relevant healthcare field plus at least 1 year experience in toxicology, chemistry, or biologics regulation.
Experience conducting internal audits and preparing for regulatory inspections.
Outstanding written and oral communication skills to draft and review SOPs, batch records, and technical reports.
Salary range: USD $97,000 to $182,200 per year, with additional benefits including medical insurance and retirement plans.