CGMP Quality Control (QC) Specialist

Job Overview

The University of Southern California (USC) is seeking a Quality Control (QC) Specialist to support manufacturing of biologics and cell and gene therapy products in its Good Manufacturing Practices (cGMP) facility. The role includes designing, developing, evaluating, and implementing quality control testing, assays, and procedures for materials and final cell therapy products, ensuring consistency with cGMP principles.

• Supports cGMP manufacturing operations with responsibility for quality control. Performs cGMP batch release testing to ensure pharmaceuticals and biopharmaceuticals are of the highest possible quality before being applied to patients. Writes and reviews qualifications, facility operation plans and reports, SOPs, and batch records as required.
• Operates instrumentation needed for cell and gene therapy manufacturing (e.g., cell counters, bioreactors, centrifuges, biological safety cabinets). Assists in technology transfer of manufacturing processes from pre‑clinical into cGMP environment.
• Provides verification of facility operations and equipment, advanced problem‑solving, troubleshooting, and consultation support. Supervises and directs junior staff to achieve project goals.
• Maintains confidentiality for patient identification, specimen labeling, and specimen verification during batch testing. Performs duties in a clean‑room environment, following cGMP guidelines and aseptic techniques.
• Attends routine meetings with the management team for progress reports on projects, facility needs, and discussion of required items. Improves current methods and evaluates innovative techniques in quality control testing for cell therapy and biologics.
• Promotes an inclusive environment that fosters equitable opportunities and upholds USC Code of Ethics.
• Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.

• Bachelor’s degree or higher in biotechnology or a closely related field.
• Demonstrated knowledge of all aspects of biotechnology and cell therapy.
• Experience with FDA regulations and clinical trials.
• Extensive leadership experience.
• Experience in cellular or biological manufacturing with quality control responsibilities.
• Knowledge of cGMP, GLP, and GDP, and of standard operating procedures in a cGMP laboratory setting.
• Excellent written and oral communication skills.
• Ability to work as an individual contributor and within a dynamic team.

• Master’s degree in biotechnology or related discipline.
• 5 years of experience in biotechnology and life sciences.

Annual base salary range: $87,576.76 – $92,000.00 per year.

Fixed‑term position, 3 years. Full‑time employment.

USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position.