Quality Control Associate

UC San Diego Health

Quality Control Associate

Extended Deadline: Thu 4/15/2021

Salary Range: Commensurate with Experience

The Department of Medicine is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel. The Advanced Cell Therapy lab is a state-of-the-art cGMP manufacturing facility whose highly skilled team will support UC and local investigators transition novel therapies through the IND and Phase I/II clinical trials.

The Quality Control Associate will focus on QC activities supporting the manufacturing of cell therapy products. This includes release and stability testing of cell therapy products, maintaining the QC laboratory and instruments, authoring and revising standard operating procedures (SOPs) & certificates of analysis, and managing off-site testing of QC samples. Works on research data reporting assignments that are of moderate diversity in scope. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

MINIMUM QUALIFICATIONS

• Bachelor's Degree in related area (scientific discipline) plus a minimum of two (2+) or more years of quality control experience OR six (6) years of quality control experience.

• Working knowledge of research function. Experience in test methods used to test cell therapy products or similar characterization assays.

• Strong skills to communicate complex information in a clear and concise manner both verbally and in writing.

• Proven skills in analysis and consultation. Strong analytical and critical thinking skills, with the ability to quickly analyze problems.

• Demonstrated experience using basic laboratory equipment; knowledge of safe laboratory procedures.

• Advanced working skills in statistical analysis, systems programming, database design and data security measures.

• Strong organizational skills with the ability to prioritize tasks and to work under the pressure of multiple demands.

• Willingness to adhere to established UCSD guidelines for safety and environmental issues.

PREFERRED QUALIFICATIONS

• Familiarity with the Miltenyi CliniMACs or similar flow cytometry devices, QPCR instruments, and absorbance readers.

• Hands-on experience in a pharmaceutical, biotech, drug manufacturing, or academic environment is required, with knowledge of clean room practices being essential.

• Strong skills using FlowLogic, MACSQuantify, FACS DIVA, or similar, as well as MS Word and Excel.

• Working knowledge of laboratory Good Manufacturing Practice (GMP), Food and Drug Administration (FDA), United States Pharmacopeial Convention (USP), and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Regulations.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check.

• Willingness to work in Biosafety Level II environment where biological (including infectious agents and blood-borne pathogens) hazards are present.

• Willingness to work with embryonic stem cells, work with viruses that are infectious to humans, including adeno-associated viruses, Sendai viruses, and lentiviral vectors which are derived from human immunodeficiency virus (HIV).

• Must be able to work various hours and locations based on business needs.

UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html