New Orleans, Louisiana
Syracuse, New York
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West Lafayette, Indiana
Saint Louis , Missouri
Chicago, Illinois
Miami, Florida
Posted: 26-Jan-22
Location: Los Angeles, California
Salary: Open
Internal Number: REQ20111303
USCâs Keck School of Medicine, Department of Medicine is seeking a dynamic individual to establish and manage Quality Assurance system for manufacturing cell and gene therapies and other biological products for internal/external users in the universityâs current Good Manufacturing Practices (cGMP) facility. Â The Quality Assurance Specialist is responsible for ensuring operations quality and compliance with current Good Manufacturing Practice (cGMP) regulations. Establishes, controls, monitors and records all activities, which directly/indirectly impact aspects of cell therapy product quality. Establishes a Corrective and Preventative Actions (CAPA) system that manages the response to errors, accidents, complaints and clinical trial-related adverse events. Ensures that cell therapy products have been produced within established process and release requirements.
Job Accountabilities:
- Supports cGMP manufacturing operations, with responsibility for quality assurance (QA). Manages internal quality improvement initiatives, evaluates internal processes, and suggests, designs, and implements improvements. Provides QA support for validations (e.g., reviewing facility operations plans, training programs, standard operating procedures) as required. Provides support with batch record documentation, all appropriate equipment log entries, and cGMP documentation.
- Manages the supplier/vendor qualification process in support of cGMP activities. Reviews and approves raw material specifications.
- 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.
- Establishes and oversees self-auditing program to ensure facilities' continual compliance with relevant regulatory requirements, working with external inspectors as needed. Manages the CAPA process, ensuring remedial actions are taken and documented when test systems deviate from established performance specifications. Works with senior staff to ensure facilities' compliance with all applicable regulations.
- Assists with validation, routine performance, and process and analytical method development to support cell therapy products. Attends routine meetings with management team for progress reports on projects, facility needs, and discussion of any other required items.
- 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. The university reserves the right to add or change duties at any time.
Successful Candidates Must Demonstrate:
- Degree 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.
This is a 3-year fixed-term position.
Minimum Education:Bachelor's degreeMinimum Experience:3 yearsMinimum Field of Expertise:Bachelor's degree in a scientific discipline (e.g., pharmaceutical, biologics). Three years' experience in cellular or biological manufacturing with quality assurance responsibilities. Demonstrated knowledge base with Good Manufacturing Practices (e.g., cGMPs, GLPs, GDPs). Experience with and knowledge of 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 Education: Masterâs degreePreferred Experience: 5 YearsPreferred Field of Expertise: Biotechnology and life sciences
