- Entry level
- No Education
- Salary to negotiate
- San Francisco
The Quality Assurance Associate will, with the guidance of the program manager and program faculty, perform quality assurance activities for the UCSF Cellular Therapy Development Laboratory and the UCSF Human Islet and Cellular Transplantation Facility (HICTF) and GMP Facility. These laboratories support a wide range of experimental cellular therapy development and manufacturing activities focusing on regulatory T cells, anti-cancer T cell therapy, CRISPR-Cas9-modified T cell therapies, and human stem cell-based therapies. The focus of the group is on first-in-human phase 1 clinical trials. We do not perform standard of care cellular therapy activities, such as hematopoetic stem cell transplants, which are handled by other UCSF facilities.
You will work with academic groups at all stages of the cellular therapy development and manufacturing process and with partners and clients in the biopharmaceutical industry who have collaborations or manufacturing activities ongoing with our group. You will work in close collaboration with the regulatory affairs, manufacturing, operations, and QC groups.
The UC San Francisco Diabetes Center is a comprehensive research and treatment facility with a broad focus on clinical care, education and both basic and clinical research. The Center maintains a multidisciplinary and highly collaborative environment that brings together expertise from the UCSF Departments of Medicine, Surgery, Pediatrics, Microbiology & Immunology and others.
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences.
• Bachelor's degree in related area and/or equivalent experience/training
• Minimum three years of experience in healthcare, biotech, or pharma QA
• Thorough knowledge of regulations governing HCT/Ps, including: cGMP, cGTP, and GLP
• Thorough knowledge of QA best practices, tools, and techniques
• Detail oriented, with proven ability to effectively manage time, see projects through to completion, organize competing priorities, and effectively address complex, urgent issues as they arise
• Strong skills required to effectively convey complex clinical and technical information both verbally and in writing and to produce high quality reports and documentation
• Strong critical thinking and problem solving skills to manage multiple levels of information and responsibilities, to quickly assess complex problems, and to develop and implement timely and effective solutions
• Strong interpersonal skills for collaborating effectively with a broad range of clinical and technical staff and representatives of external regulatory agencies and for mentoring lower-level QA staff
• At least five years of experience in healthcare, biotech, or pharma QA or equivalent
• Strong knowledge of various administrative and business software packages, and of the specialized applications for quality data management
• Strong skills to influence staff, management, and clinicians at all levels and across departments
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