QC Analyst

Location: Carlsbad, CA
Shift: 4x3 12-hour shift Sunday–Tuesday (8:00AM–8:00PM) / alternating Wednesdays, Thursday–Saturday (8:00AM–8:00PM). Periodic mandatory overtime may be required.

Key Responsibilities:
- Perform analytical testing of products, materials, and stability samples per approved laboratory procedures.
- Review and approve analytical data to support product release and ensure data integrity compliance.
- Conduct High-Performance Liquid Chromatography (HPLC) and Ultra Performance Liquid Chromatography (UPLC) testing and analysis.
- Support stability programs via protocol preparation, testing, evaluations, and technical reporting.
- Investigate deviations; support corrective and preventive actions; contribute to quality trend analysis.
- Perform equipment calibration, maintenance, and qualification.
- Execute microbiological testing, environmental monitoring, and utility sampling.
- Maintain accurate Good Manufacturing Practice (GMP) documentation and ensure compliance with laboratory quality standards.

Essential Requirements:
- Bachelor’s degree in chemistry, biochemistry, microbiology, or related scientific discipline.
- Experience performing analytical testing in a US FDA-regulated pharmaceutical manufacturing environment.
- Knowledge of GMP requirements and laboratory compliance standards.
- Experience with HPLC and related analytical techniques.
- Experience investigating deviations and supporting CAPA.
- Understanding of data integrity principles and compliant documentation practices.
- Experience calibrating, maintaining, and troubleshooting lab equipment.
- Strong communication, problem-solving, and cross-functional collaboration.

Desirable Requirements:
- Experience with endotoxin testing and/or product release testing.
- Experience with or knowledge of Empower software.