Specialist, Quality Control Analytical

Position Summary
The Specialist, Quality Control Analytical will advise testing laboratories on method development, method validation, method transfer, and quality investigations. Primary duties include data review and troubleshooting of analytical test methods.

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); review CoAs from contract testing labs; create batch release CoAs.
- Author/review lab OOS investigations and invalid test results; file internal Quality Systems reports as applicable.
- Issue ImmunityBio release Certificates of Analysis (CoAs) for QA lot disposition.
- Author/review Analytical sections of IND/BLA regulatory CMC documents.
- Provide technical expertise to troubleshoot analytical methods.
- Manage supplier change notifications and change controls.
- Generate purchase requests/orders for contract testing laboratory projects.
- Escalate QC-related issues; assist with tracking/trending data.
- Collaborate with QA and Regulatory; attend internal/external lab meetings.

Education & Experience
- Bachelor’s degree + 6+ years, or Master’s degree + 4+ years in Analytical Chemistry or related discipline.
- Experience with method development/validation/transfer, lot release tests, stability programs, and specification development.

Knowledge/Skills
- USP/EP/ICH knowledge; GMP/pharmaceutical regulations; strong technical writing; communication; collaboration; prioritization; problem solving; computer skills.

Benefits
- Medical, Dental, Vision; wellness programs; EAP; life/AD&D; short/long-term disability; FSAs; 401(k) match; 529; PTO (11 holidays; exempt = unlimited PTO; non-exempt = vacation + health pay/personal/cultural days).

Application Instructions
- Application window anticipated to close in 60 days from posting (or sooner if filled/closed).