cGMP Senior Quality Control (QC) Specialist

The Senior Quality Control (QC) Specialist at the USC/CHLA cGMP Facility will lead advanced quality control activities to ensure the quality and compliance of cell and gene therapy products. This role involves independently designing, qualifying, and optimizing complex assays, overseeing multiple projects, and collaborating closely with other teams. The QC Senior Specialist will also conduct in-depth analytical testing, establish stability programs, and create robust sampling plans while leading audits and mentoring junior staff. As a key contributor, this individual will enhance QC processes and uphold the highest regulatory standards in a dynamic, cross-functional environment.

Job Accountabilities

• Independently design, optimize, and fully qualify assays for cell and gene therapy products, ensuring each method meets regulatory standards and is robust, reliable, and reproducible.
• Oversee and manage all QC activities across multiple concurrent projects.
• Lead the planning and performance of complex analytical testing on in-process materials, raw materials, and final products to ensure they meet established specifications and stringent quality criteria.
• Troubleshoot challenging assays and develop protocols for resolving issues
• Independently trend and analyze QC assay data to identify and implement improvements.
• Design and implement robust sampling plans that cover critical steps and parameters in cell and gene therapy manufacturing processes.
• Actively collaborate with the vector development team to design, qualify, and implement QC assays specific to viral vector production.
• Perform real-time QC on manufacturing batches, support investigations related to batch failures and execute experiments that refine manufacturing-related QC processes, including environmental monitoring and contamination risk assessments.
• Act as the primary QC liaison to actively participate in cross-functional meetings with Manufacturing, Process Development, and Quality Assurance to ensure seamless coordination in product testing and release.
• Take a leadership role in internal and external audits, preparing necessary documentation and addressing QC-related queries to ensure regulatory compliance.
• Establish and lead stability testing programs to monitor the long-term quality of cell and gene therapy products.
• Create and qualify customized control and reference standards for critical assays to improve assay robustness and reproducibility.
• Act as a mentor for junior QC team members, providing guidance on assay design, troubleshooting, and best practices in data interpretation.
• Develop and train new QC and/or team members in QC/GMP related operations.
• Draft and review policies and Standard Operating Procedures (SOPs) for QC tests and operations
• Perform investigations and develop CAPAs of analytical development and QC related deviations/incidents.
• Develop QC equipment qualification and validation plans whenever necessary.
• Promotes an environment that fosters inclusive relationships and creates unbiased opportunities for contributions through ideas, words, and actions that uphold principles of the 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.
  
  
  

Successful Candidates Must Demonstrate:

Degree in a directly related specialized scientific field. Demonstrated knowledge of all aspects of biotechnology and cell therapy. Demonstrated passion for solving complex scientific issues. Experience with Food and Drug Administration regulations and clinical trials. Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.

Salary Range:

The annual salary range for this position is $87,576.76 - $115,000. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

*This is a 3 year fixed-term position.

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 for which you are applying. 

Minimum Education: Bachelor's degree in Pharmacy, Biology or in related field(s) Minimum Experience: 3 years Minimum Skills: Demonstrated knowledge base with Good Manufacturing Practices (e.g., cGMPs, GLPs, GDPs). Experience with standard operating procedures in a cGMP laboratory setting. Demonstrated ability to work as an individual contributor and in a dynamic team environment. Excellent written and oral communication skills. Preferred Education: Master's degree In Biotechnology Or in related field(s) Preferred Skills: Demonstrated knowledge of all aspects of biotechnology and cell therapy. Demonstrated passion for solving complex scientific issues. Experience with Food and Drug Administration regulations and clinical trials. Extensive leadership experience.