cGMP Quality Control Associate

University of Southern California•Los Angeles, CA

1d•$38 - $39

About The Position

The University of Southern California (USC), founded in 1880, is located in the heart of downtown L.A. and is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the “Trojan Family,” which comprises the faculty, students and staff that make the university what it is. USC’s Keck School of Medicine, current Good Manufacturing Practices (cGMP) facility is seeking a qualified cGMP Quality Control Associate to join the USC/CHLA cGMP facility. The successful candidate will play a vital role in conducting analytical testing, supporting product testing and documentation, and maintaining operations to ensure the quality and regulatory compliance of cell and gene therapy products. In addition, the cGMP Quality Control Associate will be responsible for the calibration and maintenance of laboratory equipment, drafting and reviewing Standard Operating Procedures (SOPs), and ensuring that the Quality Control (QC) laboratory remains inspection-ready at all times.

Requirements

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.
Proficiency in operating and maintaining laboratory equipment used in cGMP manufacturing and quality control testing.
Strong attention to detail and ability to follow standard operating procedures (SOPs) and Quality Assurance principles meticulously.
Excellent communication and teamwork skills to collaborate effectively with 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.
Bachelor's degree In Biotechnology Or Biological Science
3 years in cell therapy development

Nice To Haves

Master's degree
4 years in cell therapy development

Responsibilities

Performs cell culture, media preparation, cryopreservation, cell expansion, and viral vector production under strict cGMP guidelines.
Executes aseptic processing, (e.g., cell seeding, passaging, harvesting, and transduction using viral vectors).
Works closely with manufacturing, PD, QA, and QC teams to align processes, troubleshoot issues, and enhance efficiency.
Assists in process optimization, scale-up, and validation to improve yield, efficiency, and reproducibility.
Supports technology transfer from development to full-scale manufacturing.
Performs data collection and analysis to refine production parameters and enhance process consistency.
Participates in troubleshooting activities to identify process challenges and implement corrective actions.
Conducts routine cleaning, calibration, troubleshooting, and maintenance of equipment and analytical instruments to ensure compliance with cGMP standards.
Manages inventory of reagents, raw materials, and supplies, ensuring availability for seamless production and testing operations.
Performs analytical testing for product release, stability, and in-process monitoring and support in assay qualification.
Supports GMP documentation control, Corrective and Preventive Actions (CAPA) and change control processes to maintain quality standards.
Assists in internal and external audits, batch record review, and deviation investigations to uphold regulatory and quality standards.
Assists in training operators and new team members on manufacturing procedures, QC testing, and process development protocols.
Maintains compliance with all safety protocols, regulatory requirements, and workplace standards.
Encourages a workplace culture where all employees are valued, value others and have the opportunity to contribute through their ideas, words and actions, in accordance with the USC Code of Ethics.