QA Specialist, Quality Operations
ImmunityBio, Inc.
June 26, 2026
On-site
Culver City, CA
Operations
Position Summary
The QA Specialist, Quality Operations (QAO) is an individual contributor providing Quality Assurance oversight to support GMP material receipt and the manufacturing process, including quality review and disposition of documents for raw materials and manufactured products.
Essential Functions
- Review executed manufacturing batch records, analytical testing data, and certificates of analysis for accuracy, completeness, documentation quality, and cGMP/company compliance; manage issue resolution.
- Inspect and release incoming raw materials per specifications/SOPs.
- Perform QA activities supporting manufacturing operations (e.g., product label issuance/reconciliation, batch record issuance, Starting Material (Cell Banks) receipt/release/inventory, logbook issuance/management).
- Conduct product complaint investigations; determine root cause and implement CAPA.
- Initiate and investigate quality deviations; implement CAPA.
- Own quality change control tasks and provide supporting documentation.
- Perform manufacturing floor observations (practice vs. procedures, aseptic technique, media fill observations) for inspection readiness.
- Identify and implement continuous improvement to enhance GMP quality systems.
- Support internal/external compliance and regulatory audits.
- Maintain training compliance; train others as assigned.
- Create/draft/revise SOPs and controlled documents.
- Collaborate cross-functionally; complete ad-hoc duties/projects as assigned.
Education & Experience (Required/Preferred)
- BS in engineering, biological science, chemistry, or related field with 5+ years pharma/biopharma experience (or 4+ years in ImmunityBio manufacturing).
- Biologics cGMP experience (ideally recombinant protein and cell therapy) required.
- Strong quality management systems experience required.
- 2+ years QA/QC preferred.
Knowledge, Skills, & Abilities
- Strong verbal/written/interpersonal communication.
- Proficient with computers/Microsoft Office.
- Independent problem-solving; attention to detail.
- Ability to manage priorities in a fast-paced environment.
- Planning/organization to meet deadlines; experience supporting FDA/EU inspections.
Benefits
- Discretionary bonus and equity award eligibility.
- Medical, dental, and vision plan options; health and financial wellness programs; EAP; life/AD&D; short- and long-term disability; flexible spending accounts; 401(k) match; 529; PTO (11 holidays; unlimited for exempt; specific vacation/personal days for non-exempt).
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
The QA Specialist, Quality Operations (QAO) is an individual contributor providing Quality Assurance oversight to support GMP material receipt and the manufacturing process, including quality review and disposition of documents for raw materials and manufactured products.
Essential Functions
- Review executed manufacturing batch records, analytical testing data, and certificates of analysis for accuracy, completeness, documentation quality, and cGMP/company compliance; manage issue resolution.
- Inspect and release incoming raw materials per specifications/SOPs.
- Perform QA activities supporting manufacturing operations (e.g., product label issuance/reconciliation, batch record issuance, Starting Material (Cell Banks) receipt/release/inventory, logbook issuance/management).
- Conduct product complaint investigations; determine root cause and implement CAPA.
- Initiate and investigate quality deviations; implement CAPA.
- Own quality change control tasks and provide supporting documentation.
- Perform manufacturing floor observations (practice vs. procedures, aseptic technique, media fill observations) for inspection readiness.
- Identify and implement continuous improvement to enhance GMP quality systems.
- Support internal/external compliance and regulatory audits.
- Maintain training compliance; train others as assigned.
- Create/draft/revise SOPs and controlled documents.
- Collaborate cross-functionally; complete ad-hoc duties/projects as assigned.
Education & Experience (Required/Preferred)
- BS in engineering, biological science, chemistry, or related field with 5+ years pharma/biopharma experience (or 4+ years in ImmunityBio manufacturing).
- Biologics cGMP experience (ideally recombinant protein and cell therapy) required.
- Strong quality management systems experience required.
- 2+ years QA/QC preferred.
Knowledge, Skills, & Abilities
- Strong verbal/written/interpersonal communication.
- Proficient with computers/Microsoft Office.
- Independent problem-solving; attention to detail.
- Ability to manage priorities in a fast-paced environment.
- Planning/organization to meet deadlines; experience supporting FDA/EU inspections.
Benefits
- Discretionary bonus and equity award eligibility.
- Medical, dental, and vision plan options; health and financial wellness programs; EAP; life/AD&D; short- and long-term disability; flexible spending accounts; 401(k) match; 529; PTO (11 holidays; unlimited for exempt; specific vacation/personal days for non-exempt).
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).