QC Specialist

Job Description

QC Specialist (HPLC and ELISA) | 6 Month Contract-to-Hire | Biologics | San Diego, CA

George 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:

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• Lead laboratory investigations involving OOS, OOT, deviations, system suitability failures, and instrument-related issues
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• Perform Root Cause Analysis (RCA), drive CAPAs, and ensure effective long-term resolutions
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• Act as the technical SME for analytical methods and QC laboratory systems
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• Review complex analytical data and provide scientific interpretation to support GMP manufacturing
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• Support routine release and stability testing using techniques including HPLC, CE-SDS, cIEF, ELISA, and compendial methods
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• Support LIMS implementation, Empower/CDS activities, and other laboratory digital systems
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• Ensure laboratory documentation complies with GDP, ALCOA+, GMP, FDA, EMA, and ICH requirements
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• Mentor junior QC scientists and provide technical troubleshooting support
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• Work cross-functionally with QA, Manufacturing, MSAT, and Analytical Development teams
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Requirements:

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• Bachelor’s degree or higher in Biology, Biochemistry, Analytical Chemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline
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• 5+ years of experience within Quality Control in a GMP-regulated biotechnology, pharmaceutical, or CDMO environment
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• Demonstrated experience leading OOS, OOT, deviations, CAPAs, and laboratory investigations
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• Strong hands-on experience with HPLC and ELISA within a GMP-regulated biologics environment.
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• Strong understanding of GMP, GDP, ALCOA+, FDA, EMA, and ICH requirements
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• Experience with laboratory systems such as LIMS, Empower, or similar chromatography data systems
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• Excellent communication and cross-functional collaboration skills
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Preferred Experience:

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• Biologics or protein therapeutics
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• CDMO manufacturing environment
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• LIMS implementation or laboratory system improvements
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• Regulatory inspections and audit readiness
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• Continuous improvement and laboratory operational excellence
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Why This Role?

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• Initial 6 month contract with a high likelihood of permanent conversion
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• Three immediate openings across HPLC and ELISA specialisms
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• Join a rapidly growing biologics CDMO supporting innovative therapeutic programs
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• Highly visible technical role supporting investigations, laboratory systems, and QC operational excellence
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• Fast interview process with immediate starts available
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If you’re interested in learning more, feel free to apply or message George Higginson directly for a confidential discussion.