Quality Control Analyst (2nd shift)

U469 (FCRS = US469) AAA USA Inc.; United States; On-site; USD 85,000 - 159,000; Full time

Job summary

Novartis, located in Millburn, New Jersey, is seeking a Quality Control Analyst to perform chemical and microbiological testing of materials and products within a GMP environment. The role supports day-to-day QC operations, instrumentation, environmental monitoring, and investigations.

The 2nd shift (4x10) runs 3:00 pm–1:30 am, with Sun–Wed or Wed–Sun; the position offers comprehensive benefits and performance-based incentives based on experience and regulatory requirements.

Qualifications

• Bachelor's degree in Chemistry, Microbiology, or related scientific discipline.
• Minimum two years of experience in GMP or aseptic environment.
• Hands-on experience with physicochemical techniques and analytical instrumentation (HPLC, GC, iTLC).
• Knowledge of GMP regulations and FDA guidance applicable to QC testing.
• Understanding of aseptic principles including environmental monitoring and sterility testing.
• Ability to interpret analytical data and translate results into technical documentation.

Responsibilities

• Perform chemical and microbiological testing of raw materials, finished products, and packaging components.
• Execute environmental monitoring and sterility testing in GMP-compliant environments.
• Prepare, operate, clean, and maintain QC equipment, reagents, materials, and testing areas.
• Manage samples, document testing activities, report results, and escalate deviations.
• Support investigations, CAPAs, change controls, and revision of procedures and forms.
• Participate in equipment, method, and process qualification and validation activities.
• Prepare accurate analytical records and support audits and regulatory inspections.

Skills

GMP knowledge

Analytical data interpretation

Documentation practices

Environmental monitoring

Education

Bachelor's degree in Chemistry, Microbiology, or related scientific discipline

Tools

HPLC

GC

iTLC

Job description

Band Level 3 Job Description Summary Location: Millburn, New Jersey This on-site role is based in Millburn, New Jersey. Novartis is unable to offer relocation support: please only apply if accessible. Help ensure the quality and reliability of medicines that make a meaningful difference for patients.

As a Quality Control Analyst, you will perform chemical and microbiological testing of products, raw materials, and packaging components while supporting the readiness and day‑to‑day execution of Quality Control operations. You will work with analytical instrumentation, environmental monitoring, sterility testing, investigations, and documentation while maintaining high standards for quality, safety, and regulatory compliance.

Please note: This 2nd shift role will work a 4x10 schedule. Shift hours are expected to be 3:00 pm‑1:30 am either Sun – Wed or Wed – Sun.

Job Description Key Responsibilities

• Perform chemical and microbiological testing of raw materials, finished products, and packaging components.
• Execute environmental monitoring and sterility testing while maintaining compliance with GMP requirements.
• Prepare, operate, clean, and maintain Quality Control equipment, reagents, materials, and testing areas.
• Manage samples, document testing activities, report results, and elevate deviations or nonconformances.
• Support investigations, corrective and preventive actions, change controls, and associated procedure and form revisions.
• Participate in equipment, method, and process qualification and validation activities as assigned.
• Prepare accurate analytical records and support internal and external audits and regulatory inspections.

Essential Requirements

• Bachelor's degree in Chemistry, Microbiology, or another relevant scientific discipline.
• Minimum two years of experience working in a GMP or aseptic environment.
• Hands‑on experience with physicochemical techniques and analytical instrumentation, including HPLC, GC, and iTLC.
• Knowledge of GMP regulations and FDA guidance applicable to Quality Control testing.
• Understanding of aseptic principles and techniques, including environmental monitoring and sterility testing.
• Ability to interpret analytical data and translate results into clear, accurate technical documentation.

Desirable Requirements

• Experience supporting deviation investigations, corrective and preventive actions, change controls, or qualification and validation activities.
• Experience working with Quality Control testing and documentation in an RLT or radio pharmaceutical environment.

The salary for this position is expected to range between $ 85,400 and $158,600 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 $85,400.00 - $158,600.00

Skills Desired

Business Partnerships, Collaboration, Communication, Corrective and Preventive Action (CAPA), Data Integrity, Digital Fluency, GMP Operations, Good Manufacturing Practices (GMP), Managing Ambiguity, Operational Excellence, Problem Solving, Process Improvements, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management, QMS, Regulatory Compliance, Risk Management, Stakeholder Management, Standard Operating Procedure (SOP), Standard Operating Procedure (SOP) Management.

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and 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 in order to perform the essential functions of a position, please send an e‑mail to [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings