Pharma QC Analyst - HPLC, GMP, Data Integrity

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

Benefits offered by this job

Comprehensive benefits package

Generous time off

401(k) with company match

Job summary

Novartis in Carlsbad, CA seeks a QC Analyst to generate reliable analytical data for product release, stability programs, and continuous quality improvement. The role demands expertise in HPLC/UPLC, data integrity, and collaborative problem-solving in a regulated laboratory environment.

The position follows a 4x3 12-hour shift schedule with potential overtime, relocation not provided, and a strong focus on quality and regulatory compliance. Comprehensive benefits are included.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, microbiology, or related science.
• Experience in FDA-regulated pharmaceutical manufacturing.
• GMP and lab compliance knowledge.
• HPLC/UPLC analytical techniques experience.
• Experience investigating deviations and CAPA.
• Data integrity and compliant documentation understanding.
• Calibration and troubleshooting of lab instrumentation.
• Strong communication and cross-functional collaboration.

Responsibilities

• Perform analytical testing of products, materials, and stability samples.
• Review and approve analytical data for product release and data integrity.
• Conduct HPLC and UPLC testing and analysis.
• Support stability programs with protocol prep, testing, and reporting.
• Investigate deviations and support CAPA and trend analysis.
• Perform equipment calibration, maintenance, and qualification.
• Execute microbiological testing, environmental monitoring, and utility sampling.
• Maintain GMP documentation and compliance with lab standards.

Skills

Analytical testing

HPLC/UPLC

Data integrity

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in chemistry/biochemistry/microbiology

Tools

Empower software

Job description

Novartis in Carlsbad, CA seeks a QC Analyst to generate reliable analytical data for product release, stability programs, and continuous quality improvement. The role demands expertise in HPLC/UPLC, data integrity, and collaborative problem-solving in a regulated laboratory environment.

The position follows a 4x3 12-hour shift schedule with potential overtime, relocation not provided, and a strong focus on quality and regulatory compliance. Comprehensive benefits are included.