QC Specialist
al solutionsSan Diego, CA
QC Specialist (HPLC and ELISA) | 6 Month Contract-to-Hire | Biologics | San Diego, CAGeorge Higginson is currently partnered with a leading biologics CDMO that is expanding its Quality Control team in San Diego. As part of this growth, they are looking to hire a QC Specialists in HPLC and ELISA on an initial 6 month contract, with a high likelihood of permanent conversion. This is an excellent opportunity to join a growing biologics organization supporting innovative therapeutic programs. This position will serve as a senior technical contributor within the QC organization, supporting analytical testing, laboratory investigations, quality systems, and operational excellence within a cGMP-regulated biologics environment. You will work closely with QC leadership to drive laboratory compliance, inspection readiness, and continuous improvement initiatives while providing technical guidance to junior team members.
Responsibilities:
- Lead laboratory investigations involving OOS, OOT, deviations, system suitability failures, and instrument-related issues
- Perform Root Cause Analysis (RCA), drive CAPAs, and ensure effective long-term resolutions
- Act as the technical SME for analytical methods and QC laboratory systems
- Review complex analytical data and provide scientific interpretation to support GMP manufacturing
- Support routine release and stability testing using techniques including HPLC, CE-SDS, cIEF, ELISA, and compendial methods
- Support LIMS implementation, Empower/CDS activities, and other laboratory digital systems
- Ensure laboratory documentation complies with GDP, ALCOA+, GMP, FDA, EMA, and ICH requirements
- Mentor junior QC scientists and provide technical troubleshooting support
- Work cross-functionally with QA, Manufacturing, MSAT, and Analytical Development teams
Requirements:
- Bachelor’s degree or higher in Biology, Biochemistry, Analytical Chemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline 5+ years of experience within Quality Control in a GMP-regulated biotechnology, pharmaceutical, or CDMO environment
- Demonstrated experience leading OOS, OOT, deviations, CAPAs, and laboratory investigations
- Strong hands-on experience with HPLC and ELISA within a GMP-regulated biologics environment.
- Strong understanding of GMP, GDP, ALCOA+, FDA, EMA, and ICH requirements
- Experience with laboratory systems such as LIMS, Empower, or similar chromatography data systems
- Excellent communication and cross-functional collaboration skills
Preferred Experience:
- Biologics or protein therapeuticsCDMO manufacturing environmentLIMS implementation or laboratory system improvements
- Regulatory inspections and audit readiness
- Continuous improvement and laboratory operational excellence
- Why This Role?
- Initial 6 month contract with a high likelihood of permanent conversion
- Three immediate openings across HPLC and ELISA specialisms
- Join a rapidly growing biologics CDMO supporting innovative therapeutic programs
- Highly visible technical role supporting investigations, laboratory systems, and QC operational excellence
- Fast interview process with immediate starts available
- If you’re interested in learning more, feel free to apply or message George Higginson directly for a confidential discussion.
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Level
Senior L5
Location
San Diego, CA
Occupation
Quality Control Analysts
Industry
Research and Development in Biotechnology (except Nanobiotechnology)
Posted
10 days ago