Analytical Development and Quality Control Associate

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Analytical Development and Quality Control Associate

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Job ID

86649

Location

Sacramento

Full/Part Time

Full Time

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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 - For full consideration, applicants are encouraged to upload license and/or certification if required of the position

• 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 <71>, <85>, <63> 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 Good Manufacturing Practice (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

Outstanding benefits and perks are among the many rewards of working for the University of California. UC Davis offers a full range of benefits, resources and programs to help you bring your best self to work, as well as to help you and your family achieve your health, wellness, financial and career goals. Learn more about the benefits below and eligibility rules by visiting either our handy Benefits Summary for UC Davis Health Employees or Benefits Summary for UC Davis Employees and our Benefits Page.

If you are represented by a union, benefits are negotiated between the University of California (UC) and your union and finalized in a contract. Read your bargaining unit's employment contract, stay abreast of current negotiations and learn about collective bargaining at UC: https://ucnet.universityofcalifornia.edu/labor/bargaining-units/index.html

• 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 as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Paid Time Off/Vacation/Sick Time as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Continuing Education (CE) allowance and Education Reimbursement Program as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Access to free professional development courses and learning opportunities for personal and professional growth
• WorkLife and Wellness programs and resources
• On-site Employee Assistance Program including access to free mental health services
• Supplemental insurance offered including additional life, short/long term disability, pet insurance and legal coverage
• Public Service Loan Forgiveness (PSFL) Qualified Employer & Student Loan Repayment Assistance Program for qualified roles
• Retirement benefit options for eligible roles including Pension and other Retirement Saving Plans. More information on our retirement benefits can be found here

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 (e.g., stairs or ladders) - 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. Work various hours on short notice: 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 - Please contact your recruiter with questions regarding which activities apply by position

• This is a critical position, as defined by UC Policy and local procedures, and as such, employment is contingent upon clearing a criminal background check(s) and may include drug screening, medical evaluation clearance and functional capacity assessment
• This is a position with direct access to or responsibility for controlled substances, high risk hazardous chemicals, biological or radioactive/nuclear materials
• This position is designated as a mandated reporter under CANRA and UC policy, and employment is contingent on compliance with applicable policies, procedures and training requirements

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

A Culture of Opportunity and Belonging

At UC Davis, we're committed to solving life's most urgent challenges and building a healthier, more resilient world. We believe in growing through every challenge, continually striving to improve, and welcoming new perspectives that strengthen our community. We recognize that a vibrant and innovative organization values both individual strengths and shared purpose. The best ideas often emerge when people with different experiences come together.

As you consider joining UC Davis, we invite you to explore our Principles of Community, our Clinical Strategic Plan and strategic vision for research and education. We believe you belong here. 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.

To view the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

Because we want you to feel seen and valued, our recruitment process at UC Davis supports openness and authenticity. Research shows that some individuals hesitate to apply unless they meet every qualification. You may be an excellent fit for this role-or the next one. We encourage you to apply even if your experience doesn't match every listed requirement. #YouBelongHere

To learn more about our background check program, please visit: https://hr.ucdavis.edu/departments/recruitment/ucd/selection/background-checks

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