QC Specialist

AL Solutions; San Diego (CA); On-site; USD 69,000 - 83,000; Full time

Job summary

AL Solutions, a leading biologics CDMO in San Diego, seeks a QC Specialist with deep ELISA expertise for a six-month contract with a strong chance of conversion. The role sits in the Quality Control organization, focusing on ELISA testing, method implementation, investigations, and CAPA in a cGMP biologics environment.

You will perform GMP ELISA testing, prepare standards and reagents, troubleshoot assays, and mentor junior analysts while collaborating with QA, Manufacturing, and Analytical

Qualifications

• Bachelor’s degree or higher in biology, biochemistry, biotechnology, pharmaceutical sciences or related discipline.
• 5+ years of GMP QC experience in biotech/pharma/CDMO.
• Recent hands-on ELISA experience within a GMP-regulated biologics environment.
• Experience supporting GMP release and stability testing.
• Experience with method qualification, validation or transfer.
• Strong investigations experience across OOS/OOT, deviations, root-cause analysis and CAPAs.
• Experience with regulated lab systems (LIMS, plate-reader software).

Responsibilities

• Perform and review GMP ELISA testing for in-process, release and stability samples.
• Prepare standards, controls, reagents and assay plates meeting acceptance criteria.
• Troubleshoot assay variability, failed controls, standard curves and system-suitability failures.
• Support ELISA method qualification, validation or transfer.
• Lead investigations of OOS/OOT results and deviations.
• Perform root-cause analysis and verify CAPA effectiveness.
• Review data and provide interpretation to support GMP manufacturing.
• Ensure GDP, ALCOA+, GMP, FDA/EMA/ICH compliance documentation.
• Mentor junior analysts and provide technical troubleshooting.
• Collaborate with QA, Manufacturing, MSAT and Analytical Development.

Skills

ELISA expertise

GMP experience

Troubleshooting ELISA

Cross-functional collaboration

Quality documentation

Education

Bachelor’s degree in Biology/Biochemistry/Biotech

Tools

LIMS

Plate-reader software

Job description

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 Specialist with deep ELISA expertise on an initial six-month contract, with a high likelihood of permanent conversion.

This position will serve as a senior technical contributor within the QC organisation, supporting ELISA testing, method implementation, laboratory investigations and quality systems within a cGMP-regulated biologics environment.

Responsibilities:

• Perform and review GMP ELISA testing for in-process, release and stability samples
• Prepare standards, controls, reagents and assay plates while ensuring all acceptance criteria are met
• Troubleshoot assay variability, failed controls, standard curves and system-suitability failures
• Support ELISA method qualification, validation, transfer and implementation into routine QC testing
• Lead investigations involving OOS/OOT results, deviations and atypical laboratory events
• Perform root-cause analysis, implement CAPAs and verify their effectiveness
• Review analytical data and provide scientific interpretation to support GMP manufacturing
• Ensure documentation complies with GDP, ALCOA+, GMP, FDA, EMA and ICH requirements
• Mentor junior analysts and provide technical troubleshooting support
• Collaborate with QA, Manufacturing, MSAT and Analytical Development

Requirements:

• Bachelor’s degree or higher in Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences or a related discipline
• Five or more years of experience within GMP Quality Control in biotechnology, pharmaceuticals or a CDMO
• Strong recent hands‑on conventional ELISA experience within a GMP-regulated biologics environment
• Experience supporting GMP release and stability testing
• Demonstrated experience troubleshooting ELISA methods and investigating assay failures
• Experience with method qualification, validation or transfer
• Strong investigations experience across OOS/OOT results, deviations, root‑cause analysis and CAPAs
• Experience with LIMS, plate‑reader software or other regulated laboratory systems
• Excellent communication and cross‑functional collaboration skills

Preferred Experience:

• Biologics, monoclonal antibodies or protein therapeutics
• HPLC, CE‑SDS, cIEF, SDS‑PAGE or other biologics analytical techniques
• CDMO manufacturing
• Regulatory inspections and audit readiness
• Laboratory‑system implementation or continuous‑improvement projects

Why This Role?

• Initial six-month contract with a high likelihood of permanent conversion
• Competitive rate of $50‑$60 per hour on a W‑2 basis
• Join a rapidly growing biologics CDMO preparing for commercial manufacturing
• Highly visible technical role supporting ELISA implementation, investigations and QC operational excellence
• Fast interview process with immediate starts available