Senior QC Specialist - Flow Cytometry & Cell-Based Assays

Allogene Therapeutics; Newark (CA); On-site; USD 145,000 - 160,000; Full time

Benefits offered by this job

Annual performance bonus

Equity

Health insurance

Generous time off (2 company-wide shut

2 annual holiday shutdowns

Job summary

Allogene Therapeutics in Newark, CA is seeking a Senior Quality Control Specialist to provide SME oversight of QC analytical methods (flow cytometry, ELISA, qPCR/ddPCR) and review/test records in a GMP environment.

The role requires 8+ years in GMP QC, strong problem-solving and writing skills, and will lead method development/validation, CAPA, and cross-functional interactions on-site five days a week.

Qualifications

• Minimum 8 years in GMP environments with relevant QC activities.
• Broad knowledge of cell-based assays, flow cytometry, ELISA, qPCR and ddPCR.
• Experience in analytical method development/validation/transfer and reagent qualification.
• Ability to troubleshoot and optimize methods; perform CAPA investigations.
• Familiarity with GMP audits and inspection-related support.
• Strong scientific writing, time management, and collaboration skills.

Responsibilities

• Act as SME for QC test methods (flow cytometry, cell-based assays, ELISA, qPCR/ddPCR).
• Review and approve QC/test records and support CTLs as needed.
• Lead method development, validation and transfer activities; DOE support.
• Support CAPA, deviations, and change control; oversee reference standards programs.
• Troubleshoot analytical methods and improve efficiency; ensure SOP/compliance.
• Assist with GMP audits and cross-functional meetings; ensure timely testing.
• Perform QC testing for release and stability of final products as required.

Skills

Cell-based assays

Flow cytometry

ELISA

qPCR

ddPCR

GMP compliance

Analytical problem solving

Technical writing

Time management

Education

Bachelor's degree in a scientific discipline

Master of Science (MS)

PhD

Tools

JMP

Microsoft Office

Job description

Allogene Therapeutics in Newark, CA is seeking a Senior Quality Control Specialist to provide SME oversight of QC analytical methods (flow cytometry, ELISA, qPCR/ddPCR) and review/test records in a GMP environment.

The role requires 8+ years in GMP QC, strong problem-solving and writing skills, and will lead method development/validation, CAPA, and cross-functional interactions on-site five days a week.