cGMP Quality Control Associate jobs in United States
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University of Southern California · 2 hours ago

cGMP Quality Control Associate

positionLos Angeles, CA
timeFull-time
remoteOnsite
seniorityMid Level
money$37.72/hr - $38.50/hr
date3+ years exp

The University of Southern California (USC) is a prestigious research university located in downtown L.A. They are seeking a cGMP Quality Control Associate to conduct analytical testing and maintain quality and regulatory compliance for cell and gene therapy products. The role involves various responsibilities including equipment maintenance, process optimization, and ensuring compliance with safety and quality standards.

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H1B Sponsor Likelynote

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

Qualification

CGMP complianceCell therapy developmentAnalytical testingLaboratory equipment maintenanceRegulatory knowledgeTroubleshooting skillsCommunicationTeamwork skillsAttention to detail

Required

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
Bachelor's degree in Biotechnology or Biological Science
3 years in cell therapy development
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

Master's degree
4 years in cell therapy development

Company

University of Southern California

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University of Southern California is a private research university offering opportunities for interdisciplinary study and collaboration.
dateFounded in 1880
location
Los Angeles, California, USA
people-size10001+ employees
web-link
http://www.usc.edu

H1B Sponsorship

University of Southern California has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (253)
2024 (239)
2023 (172)
2022 (207)
2021 (182)
2020 (195)

Funding

Current Stage
Late Stage
Total Funding
$19.64M
Key Investors
Patient-Centered Outcomes Research InstituteCalifornia Institute for Regenerative MedicineCDA Foundation
2025-02-04Grant· $10.8M
2025-01-30Grant· $5.93M
2024-07-30Grant

Leadership Team

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David A Barnhart
Director, USC Space Engineering Research Center
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H
Hossein Pourmand
Assistant Vice President, Research Initiatives, University Advancement
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