QC Specialist
al solutionsSan Diego (CA)
About the role
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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