QC Analyst
$70,000–$130,000 year
On-siteCarlsbad, California, United States
Job Summary
Perform analytical testing of products, materials, and stability samples following approved laboratory procedures, including High-Performance Liquid Chromatography and Ultra Performance Liquid Chromatography. Review and approve analytical data to support product release and ensure data integrity compliance. Investigate deviations, support corrective and preventive actions, and contribute to quality trend analysis. Execute microbiological testing, environmental monitoring, and utility sampling while maintaining accurate Good Manufacturing Practice documentation. Conduct equipment calibration, maintenance, and qualification activities to ensure laboratory readiness. Work a 4x3 12-hour shift rotating Sunday through Tuesday and alternating Wednesdays through Saturday, with periodic mandatory overtime possible. Bachelor's degree in chemistry, biochemistry, or microbiology required with FDA-regulated pharmaceutical manufacturing experience.
Required Qualifications
- Bachelor's degree in chemistry, Biochemistry, Microbiology, or related scientific discipline
- Experience performing analytical testing in a United States Food and Drug Administration regulated pharmaceutical manufacturing environment
- Knowledge of Good Manufacturing Practice requirements and laboratory compliance standards
- Experience with High-Performance Liquid Chromatography and related analytical laboratory techniques
- Demonstrated experience investigating deviations and supporting corrective and preventive action activities
- Understanding of data integrity principles and compliant laboratory documentation practices
- Experience calibrating, maintaining, and troubleshooting laboratory equipment and instrumentation
- Strong communication, problem-solving, and cross-functional collaboration skills
- Must be available for 4x3 12-hour shift Sunday to Tuesday, 8:00AM - 8:00PM / alternating Wednesdays, Thursday - Saturday 8:00AM - 8:00PM, (Wednesday alternating every other week)
- Must be accessible to Carlsbad, CA location
- Periodic mandatory overtime may be necessary to ensure process continuity and completion
Desired Qualifications
- Experience performing endotoxin testing, product release testing, or related analytical quality control assays
- Experience with or knowledge of Empower software
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.