cGMP Quality Control Associate

Job Overview cGMP Quality Control Associate at the USC/CHLA Keck School of Medicine cGMP facility. Responsibilities Perform cell culture, media preparation, cryopreservation, cell expansion, and viral vector production under strict cGMP guidelines. Execute aseptic processing, including cell seeding, passaging, harvesting, and viral vector transduction. Collaborate with manufacturing, PD, QA, and QC teams to align processes, troubleshoot issues, and enhance efficiency. Assist in process optimization, scale‑up, and validation to improve yield, efficiency, and reproducibility. Support technology transfer from development to full‑scale manufacturing. Collect and analyze data to refine production parameters and enhance process consistency. Participate in troubleshooting activities, identify process challenges, and implement corrective actions. Conduct routine cleaning, calibration, troubleshooting, and maintenance of equipment and analytical instruments to comply with cGMP standards. Manage inventory of reagents, raw materials, and supplies to ensure seamless production and testing operations. Perform analytical testing for product release, stability, and in‑process monitoring; support assay qualification. Assist in GMP documentation control, CAPA, and change control processes to maintain quality standards. Assist in internal and external audits, batch record review, and deviation investigations. Assist in training operators and new team members on manufacturing procedures, QC testing, and process development protocols. Maintain compliance with all safety protocols, regulatory requirements, and workplace standards. Encourage a workplace culture that values all employees. Qualifications Bachelor’s degree in Biotechnology or Biological Science. Minimum 3 years of experience in cell therapy development. Proficiency in operating and maintaining laboratory equipment used in cGMP manufacturing and QC testing. Strong attention to detail and ability to follow SOPs and QA principles meticulously. Excellent communication and teamwork skills for collaboration across cross‑functional teams. Ability to troubleshoot and resolve technical issues in a timely manner. Knowledge of regulatory requirements and guidelines (e.g., FDA, EMA) related to cGMP. Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment. Experience with FDA regulations and clinical trials. Passion for solving complex scientific issues. Preferred Qualifications Master’s degree. Minimum 4 years of experience in cell therapy development. Compensation Hourly rate: $37.72 – $38.50 per hour. Salary may vary based on scope and responsibilities, experience, education, and other factors. Equal Employment Opportunity USC is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. Accommodations USC provides reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the hiring process should contact USC Human Resources at View phone number on click.appcast.io or View email address on click.appcast.io. #J-18808-Ljbffr University of Southern California