Lead Analyst, Quality Control
Listed on 2026-09-13
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers
Support the Quality and Release of Life-Saving Biopharmaceuticals
Ideal opportunity for experienced Quality Control professionals with strong analytical testing expertise in GMP biologics manufacturing environments
Are you passionate about quality control, analytical testing, and biologics manufacturing
?
We're looking for a Lead Analyst, Quality Control to join a growing Quality Control team supporting manufacturing, validation, process development, and stability studies in a GMP environment.
What You'll Do- Lead and coordinate visual inspection activities supporting product lot release
- Execute assay qualification, method validation, special studies, investigations, and technology transfer projects
- Perform and review cell-based assays, ELISA, qPCR, immunoblot, electrophoresis, and other analytical testing activities
- Conduct aseptic sampling and routine laboratory testing including pH, conductivity, osmolality, and spectrophotometry
- Serve as a Subject Matter Expert for multiple testing methodologies and laboratory instruments
- Provide guidance and technical support to Junior Analysts and Analysts
- Review, revise, and author SOPs, test methods, study protocols, reports, and specifications
- Participate in regulatory inspections, continuous improvement initiatives, and cross-functional quality activities
- Bachelor's degree in Biology, Biochemistry, Chemistry, or an equivalent scientific field
- Minimum 6 years of relevant hands-on experience working in a GMP environment
- Experience with analytical testing and equipment, writing reports, procedures, specifications, GMPs, and regulatory audits
- Strong Cell-Based Assay, qPCR, ELISA, Analytical Biochemistry and/or Chemistry experience
Hourly Rate: $46.15 - $57.69 per hour
Additional compensation and benefits package available
Please NoteOn-site in Tustin, CA
Full-time Quality Control laboratory position
Schedule is Monday through Friday, 8:00 AM to 5:00 PM
Ability to work overtime and/or weekends when necessary
#Biotech Jobs #Quality Control #QC #GMP #Biologics #Cell Based Assays #qPCR #ELISA #Analytical Chemistry #Life Sciences #Hiring #TustinCA
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