cGMP Quality Control (QC) Specialist

University of Southern California•Los Angeles, CA

21h•$87,577 - $92,000•Onsite

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 is comprised of the faculty, students and staff that make the university what it is. USC’s Keck School of Medicine, Department of Medicine is seeking a dynamic individual to work on the manufacturing of biologics and drugs for cell and gene therapy of internal/external users in the university’s current Good Manufacturing Practices (cGMP) facility. The Quality Control (QC) Specialist is responsible for designing, developing, evaluating, and implementing quality control testing, assays, and procedures for materials and final cell therapy products manufacturing. The position will also be responsible for ensuring consistency with current Good Manufacturing Practice (cGMP) principles.

Requirements

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.
Bachelor's degree in a scientific discipline (e.g., pharmaceutical, biologics).
Three 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.

Nice To Haves

Master’s Degree
5 Years
Biotechnology and life sciences

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.