QC Analyst

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

Summary

Imagine being part of a team that helps ensure every product reaching patients meets the highest standards of quality, safety, and compliance. As a QC Analyst, you will play a critical role in generating reliable analytical data that supports product release, stability programs, and continuous quality improvement. Working in a collaborative laboratory environment, you’ll apply your scientific expertise to solve complex challenges, strengthen quality operations, and help deliver medicines that make a meaningful difference for patients.

Summary

Imagine being part of a team that helps ensure every product reaching patients meets the highest standards of quality, safety, and compliance. As a QC Analyst, you will play a critical role in generating reliable analytical data that supports product release, stability programs, and continuous quality improvement. Working in a collaborative laboratory environment, you’ll apply your scientific expertise to solve complex challenges, strengthen quality operations, and help deliver medicines that make a meaningful difference for patients.

About The Role

Location: Carlsbad, CA

Relocation Support: This role is based in Carlsbad, CA. Novartis is unable to offer relocation support: please only apply if accessible.

Shift: 4x3 12-hour shift Sunday to Tuesday, 8:00AM - 8:00PM / alternating Wednesdays, Thursday - Saturday 8:00AM - 8:00PM, (Wednesday alternating every other week). Periodic mandatory overtime may be necessary to ensure process continuity and completion.

Key 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 High-Performance Liquid Chromatography and Ultra Performance Liquid Chromatography 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 Good Manufacturing Practice 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 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.

Desirable Requirements

• Experience performing endotoxin testing, product release testing, or related analytical quality control assays.
• Experience with or knowledge of Empower software

The salary for this position is expected to range between $70,000 and $130,000 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.

In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility & Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.