cGMP Quality Control (QC) Specialist

About the role

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.

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).
• Affords assistance in technology transfer of manufacturing processes from pre-clinical into cGMP environment.
• Maintains confidentiality for patient identification, specimen labeling, and specimen verification during batch testing.
• 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.

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.

Qualifications

• Minimum Education: Bachelor's degree
• Minimum Experience: 3 years
• Supervises: May lead one or more employees performing similar work
• Minimum Field of Expertise: 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.

Skills

• Knowledge of Good Manufacturing Practices (cGMPs, GLPs, GDPs)
• Experience with standard operating procedures in a cGMP laboratory setting
• Leadership experience
• Excellent written and oral communication skills

Benefits

Not specified

Pay

The annual base salary range for this position is $87,576.76 - $92,000. 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.

Schedule

Fixed-term position for 3 years.