QC Specialist

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:

• 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 therapeutics
• CDMO manufacturing environment
• LIMS 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.