University of Southern California
cGMP Quality Control Associate
University of Southern California, Los Angeles, California, United States, 90079
Job Accountabilities
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.
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 hourly rate range for this position is $37.72 - $38.50. 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.
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 Biotechnology or Biological Science. Minimum Experience: 3 years in cell therapy development. Minimum Skills: 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. Preferred Education: Master's degree. Preferred Experience: 4 years in cell therapy development.
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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.
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 hourly rate range for this position is $37.72 - $38.50. 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.
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 Biotechnology or Biological Science. Minimum Experience: 3 years in cell therapy development. Minimum Skills: 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. Preferred Education: Master's degree. Preferred Experience: 4 years in cell therapy development.
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