Pharma QC Analyst - HPLC, Data Integrity & Release Support

Novartis Group Companies; Carlsbad (CA); On-site; USD 70,000 - 130,000; Full time

Job summary

Novartis Group Companies in Carlsbad, CA, is seeking a QC Analyst to ensure product quality through analytical testing, data integrity, and deviation investigations. You will perform HPLC/UPLC analyses, support stability programs, and maintain GMP-compliant records in a fast-paced laboratory environment.

The role requires a bachelor’s degree in a chemical or biological science, FDA-regulated experience, and strong problem-solving and cross-functional collaboration skills.

Qualifications

• Bachelor's degree in chemistry, biochemistry, microbiology, or related scientific discipline.
• Experience performing analytical testing in a United States FDA 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.

Responsibilities

• Perform analytical testing of products, materials, and stability samples following approved laboratory procedures.
• Review and approve analytical data to support product release and ensure data integrity compliance.
• Conduct HPLC and UPLC testing and analysis.
• Support stability programs through protocol preparation, testing, evaluations, and technical reporting.
• Investigate deviations, support corrective and preventive actions, and contribute to quality trend analysis.
• Perform equipment calibration, maintenance, and qualification activities to ensure laboratory readiness.
• Execute microbiological testing, environmental monitoring, and utility sampling to support quality operations.
• Maintain accurate GMP documentation and ensure compliance with laboratory quality standards.

Skills

Analytical testing

Data integrity

Deviations investigation

Laboratory documentation

Communication

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in chemistry, biochemistry, microbiology, or related field

Tools

Empower software

Job description

Novartis Group Companies in Carlsbad, CA, is seeking a QC Analyst to ensure product quality through analytical testing, data integrity, and deviation investigations. You will perform HPLC/UPLC analyses, support stability programs, and maintain GMP-compliant records in a fast-paced laboratory environment.

The role requires a bachelor’s degree in a chemical or biological science, FDA-regulated experience, and strong problem-solving and cross-functional collaboration skills.