QC Analyst

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

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'llapply your scientificexpertiseto solve complex challenges, strengthen quality operations, and help deliver medicines that make a meaningful difference for patients.

Job Description

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 Wednesday - Sunday 8:00AM- 8:00PM / Thursday - Saturday 8:00AM - 8:00PM, 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.

Salary Range

$70,000.00 - $130,000.00

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 and reasonable accommodations

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 [e-mail] 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.

Skills Desired

Collaboration, Data Integrity, Deadline Adherence, Decision Making, Leadership