Analytical Development and Quality Control Associate

Job Summary The Staff Research Associate 3 position serves as a Quality Control (QC) Associate for the Good Manufacturing Practice (GMP) Facility at the UC Davis Health campus in Sacramento. The QC Associate supports GMP testing activities for cell therapy, gene therapy, and related biological products manufactured within the UC Davis GMP Facility. This position performs in-process and release testing assays in compliance with FDA regulations, USP standards, FACT requirements, and internal Standard Operating Procedures (SOPs). The incumbent executes analytical methods, ensures accurate data documentation in accordance with Good Documentation Practices (GDP), and supports QC deviation investigations. This role requires strong laboratory skills, attention to detail, and strict adherence to regulatory and quality standards within a clinical manufacturing environment. Apply By Date 6/17/2026 by 11:59pm Minimum Qualifications Bachelor’s degree in Biology, Molecular Biology, Biochemistry, Bioengineering, or related scientific field. 1–3 years laboratory experience in a regulated or research environment. Experience performing analytical assays. Experience with aseptic technique. Working knowledge of Good Documentation Practices (GDP). Advanced understanding of GMP fundamentals. Demonstrated ability to follow detailed SOPs. Demonstrated organizational and time management skills. Demonstrated written and verbal communication skills. Preferred Qualifications Experience in GMP, GLP, or regulated laboratory environment. Experience with GMP manufacturing of drug formulations and GMP storage of such drug formulations. Experience in cell therapy or gene therapy QC testing. Experience with flow cytometry, PCR platforms, or immunoassays. Familiarity with USP sterility and endotoxin testing. Knowledge of 21 CFR 210/211 and/or 1271. General knowledge of USP testing requirements. Experience using data analysis software (FlowJo, Excel, JMP, etc.). Demonstrated ability to work in cleanroom gowning environments. Key Responsibilities 35% – GMP Quality Control Testing 20% – Assay Development 20% – Documentation & Compliance 10% – Equipment & Laboratory Maintenance 10% – Deviations & Investigations 5% – Training & Continuous Department Overview The Good Manufacturing Practice Facility (GMP) is a large operation within the Stem Cell Research Program at the UC Davis Health campus in Sacramento and is the largest academic GMP facility in Northern California. The purpose of the GMP Facility is to manufacture clinical grade stem cell and other cellular therapy products, gene therapy products, pharmaceutical products and formulations for novel or routine patient treatment and clinical trials under strict adherence to FDA regulations. The GMP currently manufactures products for University investigators as well as other academic and industry partners. Position Information Salary or Pay Range: $2,752.80 - $4,426.40 Salary Frequency: Bi-Weekly Salary Grade: 105 UC Job Title: SRA 3 UC Job Code: 009611 Number of Positions: 3 Appointment Type: Staff: Career Percentage of Time: 100% Shift (Work Schedule): Day Location: UCD Inst for Regenerative Cure (HSP041) Union Representation: RX-Research Professionals Benefits Eligible: Yes This position is 100% on-site Benefits High quality and low-cost medical plans to choose from to fit your family's needs UC pays for Dental and Vision insurance premiums for you and your family Extensive leave benefits including Pregnancy and Parental Leave, Family & Medical Leave Paid Holidays annually Paid Time Off/Vacation/Sick Time Continuing Education allowance and Education Reimbursement Program Access to free professional development courses and learning opportunities WorkLife and Wellness programs and resources On-site Employee Assistance Program including free mental health services Supplemental insurance offered including additional life, short/long term disability, pet insurance and legal coverage Public Service Loan Forgiveness qualified employer & student loan repayment assistance program for qualified roles Retirement benefit options including Pension and other Retirement Saving Plans Physical Demands Standing – Frequent 3 to 6 Hours Walking – Frequent 3 to 6 Hours Sitting – Occasional Up to 3 Hours Lifting/Carrying 0-25 Lbs – Occasional Up to 3 Hours Pushing/Pulling 0-25 Lbs – Occasional Up to 3 Hours Bending/Stooping – Occasional Up to 3 Hours Squatting/Kneeling – Occasional Up to 3 Hours Twisting – Occasional Up to 3 Hours Climbing – Occasional Up to 3 Hours Reaching overhead – Occasional Up to 3 Hours Keyboard use/repetitive motion – Frequent 3 to 6 Hours Environmental Demands Chemicals, dust, gases, or fumes – Frequent 3 to 6 Hours Marked changes in humidity or temperature – Frequent 3 to 6 Hours Microwave/Radiation – Frequent 3 to 6 Hours Operating motor vehicles and/or equipment – Frequent 3 to 6 Hours Extreme Temperatures – Occasional Up to 3 Hours Uneven Surfaces or Elevations – Occasional Up to 3 Hours Mental Demands Sustained attention and concentration – Continuous 6 to 8+ Hours Complex problem solving/reasoning – Frequent 3 to 6 Hours Ability to organize & prioritize – Continuous 6 to 8+ Hours Communication skills – Continuous 6 to 8+ Hours Numerical skills – Frequent 3 to 6 Hours Constant Interaction – Frequent 3 to 6 Hours Multiple Concurrent Tasks – Frequent 3 to 6 Hours Work Environment UC Davis is a smoke and tobacco free campus effective January 1, 2014. Smoking, the use of smokeless tobacco products, and the use of unregulated nicotine products (e-cigarettes) will be strictly prohibited on any UC Davis owned or leased property, indoors and outdoors, including parking lots and residential space. Shift work and/or weekend work may be required at times. The position is subject to Medical Surveillance procedures and review in accordance with federal and state laws and regulations and University policy, and work under regular exposure to zoonotic diseases anesthetic agents, cleaning chemicals and radiation producing devices. Special Requirements Criminal background check, drug screening, medical evaluation clearance, functional capacity assessment required. Direct access to or responsibility for controlled substances, high risk hazardous chemicals, biological or radioactive/nuclear materials. Mandated reporter under CANRA and UC policy, employment contingent on compliance with applicable policies, procedures and training requirements. EEO Statement The University of California, Davis is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. #J-18808-Ljbffr University of California, Davis