University of Southern California · 2 months ago
cGMP Quality Control (QC) Specialist
Los Angeles, CA
Full-time
Onsite
Mid, Senior Level
$88K/yr - $92K/yr
3+ years expThe University of Southern California (USC) is a world-class research university located in downtown L.A. and is seeking a cGMP Quality Control (QC) Specialist to work on the manufacturing of biologics and drugs for cell and gene therapy. The role involves designing and implementing quality control testing and ensuring compliance with cGMP principles while supporting manufacturing operations and supervising junior staff.
EducationHigher EducationUniversities
Responsibilities
Supports cGMP manufacturing operations with responsibility for quality control
Performs cGMP batch release testing to ensure pharmaceuticals and biopharmaceuticals are of the highest possible quality before being applied to patients
Writes and reviews qualifications (e.g., installation, operation, performance), facility operation plans and reports, standard operating procedures, and batch records as required
Completes batch record documentation, all appropriate equipment log entries, and cGMP documentation
Operates instrumentation needed for cell and gene therapy manufacturing (e.g., cell counters, bioreactors, centrifuges, biological safety cabinets)
Assists in technology transfer of manufacturing processes from pre-clinical into cGMP environment
Provides verification of facility operations and equipment, along with advanced problem-solving, troubleshooting, and consultation support, as needed
Supervises and directs junior staff to achieve project goals
Serves as a resource to cGMP facility management in identifying and assessing the appropriate complement of resources and support needed to successfully implement and execute projects
Maintains confidentiality for patient identification, specimen labeling, and specimen verification during batch testing
Performs duties in a clean room environment, when needed and while fully gowned (e.g., mask, coverall, gloves), following cGMP guidelines and using aseptic techniques
Works with senior staff to ensure facilities' compliance with all applicable regulations
Attends routine meetings with the management team for progress reports on projects, facility needs, and discussion of any other required items
Improves current methods and evaluates innovative techniques in quality control testing for cell therapy and biologics
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
Qualification
Required
Bachelor's degree or higher in biotechnology or closely related 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
Extensive leadership experience
Minimum 3 years' experience in cellular or biological manufacturing with quality control responsibilities
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
Master's Degree
5 Years experience in biotechnology and life sciences
Company
University of Southern California
University of Southern California is a private research university offering opportunities for interdisciplinary study and collaboration.
10001+ employees
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 StageTotal Funding
$19.64MKey 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
David A Barnhart
Director, USC Space Engineering Research Center
H
Hossein Pourmand
Assistant Vice President, Research Initiatives, University Advancement
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