QC Specialist
AL Solutions · San Diego, California, United States
FULL TIME
Job Description
QC Specialist (HPLC and ELISA) | 6 Month Contract-to-Hire | Biologics | San Diego, CA
Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.
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 issuesPerform Root Cause Analysis (RCA), drive CAPAs, and ensure effective long-term resolutionsAct as the technical SME for analytical methods and QC laboratory systemsReview complex analytical data and provide scientific interpretation to support GMP manufacturingSupport routine release and stability testing using techniques including HPLC, CE-SDS, cIEF, ELISA, and compendial methodsSupport LIMS implementation, Empower/CDS activities, and other laboratory digital systemsEnsure laboratory documentation complies with GDP, ALCOA+, GMP, FDA, EMA, and ICH requirementsMentor junior QC scientists and provide technical troubleshooting supportWork 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 discipline5+ years of experience within Quality Control in a GMP-regulated biotechnology, pharmaceutical, or CDMO environmentDemonstrated experience leading OOS, OOT, deviations, CAPAs, and laboratory investigationsStrong hands-on experience with HPLC and ELISA within a GMP-regulated biologics environment.Strong understanding of GMP, GDP, ALCOA+, FDA, EMA, and ICH requirementsExperience with laboratory systems such as LIMS, Empower, or similar chromatography data systemsExcellent communication and cross-functional collaboration skills
Preferred Experience:Biologics or protein therapeuticsCDMO manufacturing environmentLIMS implementation or laboratory system improvementsRegulatory inspections and audit readinessContinuous improvement and laboratory operational excellence
Why This Role? xzbcwsv Initial 6 month contract with a high likelihood of permanent conversionThree immediate openings across HPLC and ELISA specialismsJoin a rapidly growing biologics CDMO supporting innovative therapeutic programsHighly visible technical role supporting investigations, laboratory systems, and QC operational excellenceFast 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.
Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.
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 issuesPerform Root Cause Analysis (RCA), drive CAPAs, and ensure effective long-term resolutionsAct as the technical SME for analytical methods and QC laboratory systemsReview complex analytical data and provide scientific interpretation to support GMP manufacturingSupport routine release and stability testing using techniques including HPLC, CE-SDS, cIEF, ELISA, and compendial methodsSupport LIMS implementation, Empower/CDS activities, and other laboratory digital systemsEnsure laboratory documentation complies with GDP, ALCOA+, GMP, FDA, EMA, and ICH requirementsMentor junior QC scientists and provide technical troubleshooting supportWork 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 discipline5+ years of experience within Quality Control in a GMP-regulated biotechnology, pharmaceutical, or CDMO environmentDemonstrated experience leading OOS, OOT, deviations, CAPAs, and laboratory investigationsStrong hands-on experience with HPLC and ELISA within a GMP-regulated biologics environment.Strong understanding of GMP, GDP, ALCOA+, FDA, EMA, and ICH requirementsExperience with laboratory systems such as LIMS, Empower, or similar chromatography data systemsExcellent communication and cross-functional collaboration skills
Preferred Experience:Biologics or protein therapeuticsCDMO manufacturing environmentLIMS implementation or laboratory system improvementsRegulatory inspections and audit readinessContinuous improvement and laboratory operational excellence
Why This Role? xzbcwsv Initial 6 month contract with a high likelihood of permanent conversionThree immediate openings across HPLC and ELISA specialismsJoin a rapidly growing biologics CDMO supporting innovative therapeutic programsHighly visible technical role supporting investigations, laboratory systems, and QC operational excellenceFast 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.
Details
| Company | AL Solutions |
| Location | San Diego, California, United States |
| Type | FULL TIME |
| Niche | hr |