Quality Control Analytical Analyst
Kelly® Science & Clinical is seeking a Quality Control Analytical Analyst for a 6 month contract-to-hire position in Vacaville, CA. If you’re passionate about applying analytical science in a cGMP-regulated environment and ready to take the next step in your career, trust the experts at Hiring Experts.
Pay: $35-38/hour
Schedule: M-F Dayshift Onsite
Overview
The Client is an industry-leading biotechnology company focused on the development and manufacture of therapeutic protein drug products supporting domestic and global clinical trials. The organization operates within a cGMP-compliant environment and is committed to high-quality standards, scientific excellence, and continuous improvement.
In this role, you will be responsible for performing biochemical, physical, and chemical analyses of process development, lot release, stability, and raw material samples. You will work independently on established assays, support investigations, and help maintain an inspection-ready quality control laboratory.
Responsibilities
- Perform biochemical, physical, and chemical analyses of samples under cGMP to meet established timelines
- Execute testing for process development, lot release, stability, and incoming raw materials
- Identify, document, and contribute to OOS, OOE, and OOT investigations related to testing activities
- Initiate, author, and support deviation and laboratory investigations
- Provide technical support and troubleshooting for analytical test methods
- Maintain the laboratory in a constant state of inspection readiness
- Develop and maintain proficiency across a broad range of analytical test methods
- Train other analysts on test methods and standard operating procedures
- Author change control documentation and support revision of written procedures
- Manage reagent and equipment inventory within assigned laboratory areas
- Ensure adherence to cGMP, 21 CFR, USP, EP, ICH, and other applicable regulatory requirements
- Follow all company policies, safety practices, and quality standards
Qualifications
- Bachelor’s degree in a scientific discipline (Biology, Biochemistry, Chemistry, or related field)
- Minimum of 5 years of relevant laboratory experience in a GMP-regulated environment
- Strong working knowledge of cGMP regulations, including 21 CFR 210/211, USP, EP, and ICH
- Hands-on experience with protein analytics and analytical techniques such as SDS-PAGE and HPLC
- Familiarity with chromatography data systems (e.g., OpenLab) preferred
- Experience with subvisible particle testing (USP <788>) and CCIT preferred
- Strong documentation, organizational, and communication skills
- Ability to work independently with minimal supervision and collaborate in a team environment
- Proficiency with standard computer applications (Windows, Microsoft Word, Excel)
- Ability to occasionally lift and/or move up to 25 pounds
- Vision abilities include close vision, depth perception, and ability to adjust focus
What Happens Next
Once you apply, you’ll move forward to the next steps if your skills and experience are a good match. Even if this position isn’t the right fit, you’ll remain in our network—giving our expert Science & Clinical recruiters continued access to your profile and future opportunities.
