Cell Therapy QC Analyst — CGMP Release & Methods

Regulatory Jobs; California; On-site; USD 56,000 - 84,000; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Retirement programs

Paid time off

Health, dental, and vision coverage

Job summary

AstraZeneca is seeking an energetic and experienced professional with a cell therapy quality control background to join our Quality Control team. The successful candidate will perform QC analytical method qualification, execute lot release testing, sample management and other assigned tasks in CGMP compliant conditions.

The position requires strong data analysis, documentation, and collaboration across teams.

Qualifications

• Bachelor's or Associate degree in Biology with CGMP lab experience.
• Strong attention to detail and good communication.
• Experience with sample receipt, storage and transfer.

Responsibilities

• Perform CGMP release and stability testing (e.g., flow cytometry, ELISA, qPCR/dPCR) for cell therapy samples.
• Receive, verify, label, store, and track samples and reagents for traceability.
• Author/review analytical test results and SOPs; prepare protocols/reports.
• Document activities and maintain CGMP-compliant records.
• Execute method qualification, verification, validation, and tech transfer support.
• Escalate and document invalid, OOS/OOT results; support deviations and CAPAs.
• Follow safety procedures and maintain a clean, compliant lab environment.
• Perform other duties as assigned.

Skills

Attention to detail

Communication skills

Data analysis

Team collaboration

Education

Bachelor's degree in Biology or CGMP lab experience

Associate's degree in Biology or CGMP lab experience

Tools

Microsoft Outlook

Word

Excel

Job description

AstraZeneca is seeking an energetic and experienced professional with a cell therapy quality control background to join our Quality Control team. The successful candidate will perform QC analytical method qualification, execute lot release testing, sample management and other assigned tasks in CGMP compliant conditions.

The position requires strong data analysis, documentation, and collaboration across teams.