Analytical Development and Quality Control Associate

Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant scientific field.
  • 1-3 years of laboratory experience in a regulated environment.
  • Experience in performing analytical assays.
  • Proficiency in aseptic technique and GDP principles.
  • Strong understanding of GMP regulations and documentation standards.

Responsibilities

  • Conduct GMP Quality Control testing of biological products.
  • Develop and optimize assays for product testing.
  • Maintain accurate and compliant documentation.
  • Oversee laboratory equipment and ensure proper maintenance.
  • Investigate and resolve deviations from QC standards.
  • Engage in training and continuous professional development.

Benefits

  • Comprehensive health plans tailored for families.
  • UC covers dental and vision insurance premiums.
  • Extensive leave policies including paid holidays and family leave.
  • Opportunity for continuing education and professional development.
  • Wellness programs and mental health resources available on-site.
  • Retirement options including pension and savings plans.
Full Job Description
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 , , 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 (1 of 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
  • Loud noise levels - Never 0 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
  • Customer/Patient Contact - Never 0 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.

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.

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