GMP Quality Assurance Analyst – Cell Therapy

UC Irvine; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

UC Irvine in Irvine, CA, seeks a Quality Assurance (QA) Specialist to support GMP manufacturing operations and process development in the School of Medicine's cGMP facility. You will issue/review batch records, manage deviations, CAPAs, change controls, and contribute to regulatory readiness.

The role requires a Bachelor's in Nursing or healthcare field, 1+ year in toxicology or biologics regulation, and strong documentation skills to draft SOPs and audit-ready reports.

Qualifications

• Bachelor’s degree in Nursing or healthcare field; science or medical background preferred.
• At least 1 year of experience in toxicology, chemistry, or regulation of biologics.
• Experience reviewing cGMP/GLP documents (SOPs, protocols, batch records, reports).

Responsibilities

• Support QA Unit in GMP Operations within the School of Medicine.
• Perform QA activities including label issuance, batch record review, release and product disposition.
• Manage deviations, CAPAs, and change controls; prepare for regulatory inspections.
• Collaborate with stakeholders to ensure compliance with quality systems and SOPs.
• Provide documentation support for IND submissions and regulatory readiness.

Skills

Technical vocabulary

GMP knowledge

Regulatory awareness

Documentation

Communication skills

Team collaboration

Auditing experience

Education

Bachelor's degree in Nursing or relevant healthcare profession

Tools

SOP drafting

Batch records review

Job description

UC Irvine in Irvine, CA, seeks a Quality Assurance (QA) Specialist to support GMP manufacturing operations and process development in the School of Medicine's cGMP facility. You will issue/review batch records, manage deviations, CAPAs, change controls, and contribute to regulatory readiness.

The role requires a Bachelor's in Nursing or healthcare field, 1+ year in toxicology or biologics regulation, and strong documentation skills to draft SOPs and audit-ready reports.