cGMP Quality Control (QC) Specialist

University of Southern California; Los Angeles (CA); On-site; USD 87,576 - 92,000; Full time

Job summary

A prestigious university in California is seeking a Quality Control Specialist to oversee quality assurance in a cGMP facility. You will support manufacturing operations, perform batch release testing, and supervise junior staff. Applicants must have a Bachelor's degree in biotechnology and substantial experience in cell therapy and quality control. This full-time position offers a salary range of $87,576.76 – $92,000.00 per year.

Qualifications

• Experience in cellular or biological manufacturing with quality control responsibilities.
• Demonstrated knowledge of all aspects of biotechnology and cell therapy.
• Ability to work as an individual contributor and within a dynamic team.

Responsibilities

• Support cGMP manufacturing operations with responsibility for quality control.
• Perform cGMP batch release testing.
• Supervise and direct junior staff to achieve project goals.

Skills

Biotechnology knowledge

Leadership

Knowledge of FDA regulations

Excellent communication skills

Cell therapy experience

Problem-solving

Education

Bachelor’s degree in biotechnology or related field

Job description

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.

Responsibilities

• 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.

Qualifications

• 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.

Preferred Qualifications

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

Salary

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

Position Details

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

Equal Opportunity Employer

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.