Quality Control Analyst (2nd shift)

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. Please indicate your preference when you apply. Adjustments to the schedule may be necessary based on business need.

#LI-Onsite

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 escalate 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.

To learn more about the culture, rewards and benefits we offer our people click here.

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, Quality Management Systems (QMS), Regulatory Compliance, Risk Management, Stakeholder Management, Standard Operating Procedure (SOP), Standard Operating Procedure (SOP) Management