Quality Control Specialist
Department of Laboratory Medicine

The Department of Laboratory Medicine at the University of California, San Francisco (UCSF) is seeking an experienced and motivated Quality Control (QC) Specialist to conduct quality control testing for clinical manufacturing at the UCSF Human Islet and Cellular Transplantation GMP Facility (HICTF). HICTF is a part of the Investigational Cellular Therapy (ICT) group (https://celltherapy.ucsf.edu/), which aims to accelerate the development and delivery of promising new cell and gene therapies targeting cancer, autoimmunity, infectious disease, and inherited hematologic and immune disorders. ICT has established collaborations with UCSF research groups and a variety of academic and industrial partners to develop new cell and gene therapy technologies, platforms, and products.

The successful candidate will conduct quality control activities within a highly skilled QC team, and collaborate closely with GMP Manufacturing, Quality Assurance, Operations/Facilities, and Process Development functions.

Key Responsibilities:

• Perform GMP-compliant in-process, release and and stability testing samples using a variety of analytical methods, including flow cytometry, PCR-based and cell-based assays.
• Collect, analyze, interpret, and report QC test results following Good Documentation Practices (GDocP).
• Design and execute studies supporting analytical method development, optimization, transfer, and qualification.
• Work cross-functionally with Process Development, Quality Assurance, and other functions to optimize analytical testing, product specifications, and process control strategies.
• Author, review, and revise controlled documents, including SOPs, test methods, sample plans and reports, ensuring compliance with regulatory and internal quality standards.
• Serve as a subject matter expert during technology transfer from/to external CDMOs.
• Maintain laboratory instrumentation through regular calibration, maintenance, and troubleshooting.
• Manage vendor and coordinate QC activities at contract testing labs - Investigate out-of-specification and/or non-conforming test results, and escalate as directed.
• Asepticallly process cells to initiate and maintain cell cultures/cell banks, including cryopreservation of cells.
• Manage environmental monitoring (EM) of cleanrooms, including scheduling, sampling, review, and trending of viable and non-viable particle data.
• Perform and document inspection and release of incoming raw materials, critical reagents, and supplies used in GMP manufacturing.
• Participate in root cause analyses for deviations/CAPAs, and implement corrective and preventive actions (CAPAs).
• Participate in the evaluation of suppliers and contract testing laboratories, addressing and resolving issues associated with vendors and suppliers.
• Carry out various QC support tasks, such as inventory management, which includes obtaining quotes, placing orders, managing reagent availability and control.
• Support internal and external audits, inspections, and regulatory submissions as needed. This position will occasionally involve long hours and some weekends and holidays.
• Ability to follow instructions precisely are critical to success in this position.

Required Qualifications:

• Assistant Specialist- Master's degree or a baccalaureate degree in biology, biochemistry, immunology, or a related scientific discipline with three or more years of research experience.
• Associate Specialist- Master's degree (or equivalent degree) in biology, biochemistry, immunology, or a related scientific discipline or five to ten years of experience in the relevant specialization
• Full Specialist- terminal degree (or equivalent degree) in biology, biochemistry, immunology, or a related scientific discipline or ten or more years of experience in the relevant specialization
• A minimum of 2-4 years of relevant QC experience in a GMP-regulated environment.
• Strong knowledge and hands-on experience in various analytical methods including multi-color flow cytometry and digital PCR-based assays.
• Strong scientific writing and documentation skills, with experience authoring SOPs and technical documents.
• Experience with aseptic techniques in mammalian tissue culture.
• Excellent critical thinking, attention to detail, and time management skills.
  
• Effective communication and collaboration across multidisciplinary teams.
• Eagerness to learn and contribute to the safety and development of innovative cell-based therapies.
• Candidates must meet the required qualifications at the time of appointment.
  
• Candidates' CV must state qualifications or if pending upon submission.

Preferred Qualifications:

• Experience in an academic, early-phase clinical, or hospital-based GMP facility.
• Knowledge of FDA, USP, FACT, and ICH guidelines applicable to cell therapy products.
• Experience with EM program management, data trending tools, or QC data systems.
• Experience in materials inspection/release in a GMP setting.

Please apply online at https://aprecruit.ucsf.edu/JPF05657, with a CV and three references.

See Table 24B for the salary range for this position. A reasonable estimate for this position is $63,500-$194,800.

As a University employee, you will be required to comply with all applicable University policies and/or collective bargaining agreements, as may be amended from time to time. Federal, state, or local government directives may impose additional requirements.

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

As a condition of employment, the finalist will be required to disclose if they are subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct.
* "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment, or discrimination, as defined by the employer.
* UC Sexual Violence and Sexual Harassment Policy
* UC Anti-Discrimination Policy
* APM - 035: Affirmative Action and Nondiscrimination in Employment