Specialist, Quality Control Analytical
ImmunityBio, Inc.
August 09, 2026
On-site
El Segundo, CA
Operations
Position Summary
The Specialist, Quality Control Analytical will advise testing laboratories on method development, validation, transfer, and quality investigations, including data review and troubleshooting.
Essential Functions
- Author, review, and revise SOPs, test methods, analytical method development/validation/transfer protocols & reports, and product specifications.
- Review QC stability and lot release data (data integrity check) and contract lab CoAs; create batch release CoA.
- Author/review laboratory OOS investigations and invalid test results; file internal Quality Systems reports as applicable.
- Issue ImmunityBio release Certificates of Analysis (CoAs) to support QA lot disposition.
- Author/revise the Analytical Section of IND/BLA documents for regulatory CMC submissions.
- Troubleshoot analytical methods.
- Manage supplier change notifications and change controls.
- Generate PRs/POs for contract testing laboratory projects.
- Escalate QC-related issues timely; assist in tracking/trending data.
- Collaborate with QA and Regulatory; attend internal and external meetings with contract labs.
Qualifications
- Bachelor’s degree + 6+ years (Analytical Chemistry or related) OR Master’s degree + 4+ years.
- Experience with method development/validation/transfer, lot release testing, stability programs, and specification development.
Skills/Knowledge
- Knowledge of QC analytical methods; USP, EP, and ICH guidelines.
- GMP and pharmaceutical regulations; strong technical writing.
- Communicate effectively; collaborate with labs/consultants; multitask, prioritize; strong problem solving and computer skills.
Benefits (as stated)
- Discretionary bonus and equity; Medical/Dental/Vision; PTO (11 holidays) with exempt/unlimited or non-exempt specifics; 401(k) match; and other listed wellness/welfare benefits.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
The Specialist, Quality Control Analytical will advise testing laboratories on method development, validation, transfer, and quality investigations, including data review and troubleshooting.
Essential Functions
- Author, review, and revise SOPs, test methods, analytical method development/validation/transfer protocols & reports, and product specifications.
- Review QC stability and lot release data (data integrity check) and contract lab CoAs; create batch release CoA.
- Author/review laboratory OOS investigations and invalid test results; file internal Quality Systems reports as applicable.
- Issue ImmunityBio release Certificates of Analysis (CoAs) to support QA lot disposition.
- Author/revise the Analytical Section of IND/BLA documents for regulatory CMC submissions.
- Troubleshoot analytical methods.
- Manage supplier change notifications and change controls.
- Generate PRs/POs for contract testing laboratory projects.
- Escalate QC-related issues timely; assist in tracking/trending data.
- Collaborate with QA and Regulatory; attend internal and external meetings with contract labs.
Qualifications
- Bachelor’s degree + 6+ years (Analytical Chemistry or related) OR Master’s degree + 4+ years.
- Experience with method development/validation/transfer, lot release testing, stability programs, and specification development.
Skills/Knowledge
- Knowledge of QC analytical methods; USP, EP, and ICH guidelines.
- GMP and pharmaceutical regulations; strong technical writing.
- Communicate effectively; collaborate with labs/consultants; multitask, prioritize; strong problem solving and computer skills.
Benefits (as stated)
- Discretionary bonus and equity; Medical/Dental/Vision; PTO (11 holidays) with exempt/unlimited or non-exempt specifics; 401(k) match; and other listed wellness/welfare benefits.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).