Quality Control Scientist

Work Your Magic with us! Start your next chapter and join Millipore Sigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our diverse people, customers, patients, and planet.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

The Scientist, Quality position is responsible for the cGMP analytical laboratory analysis review in the Quality Control department of Millipore Sigma. Analysis may include incoming raw material analysis, in-process testing, final product analysis, stability, reference standard requalification, method validation/qualification, cleaning, and environmental monitoring to support Quality Control activities at the Madison and Verona sites. Techniques include HPLC, GC, KF, DSC, TGA, IR, MS, NMR, LC‑MS and other tests.

Other responsibilities include initiation and review of deviations, OOS/OOT’s, change controls, and CAPA’s; participation in process improvement initiatives; maintaining a clean and safe work area; and supporting laboratory audit readiness.

• Analyze complex cGMP data to identify root causes and implement effective CAPAs with minimal oversight.
• Perform in-depth analytical data review in support of QC, ensuring accuracy, integrity, and compliance with ALCOA+ principles.
• Prioritize and coordinate in-process testing reviews with manufacturing and laboratory teams to minimize downtime.
• Author and manage complex deviations, investigations, change controls, CAPAs, and OOS/OOT activities, communicating status to stakeholders.
• Review and support method development, validation, transfers, product changeovers, and ICP‑MS testing for routine QC analysis.
• Maintain audit‑ready laboratory operations, including safety, housekeeping, reagent management, waste disposal, and equipment qualification review (IQ/OQ/PV).
• Provide peer review, technical documentation, and training support for laboratory staff while upholding data integrity and “right first time” principles.
• Collaborate cross-functionally to manage projects and timelines while ensuring compliance with ICH Q7, 21 CFR Parts 11/210/211, and applicable regulatory standards.

• Work in an analytical testing laboratory with hazardous and toxic chemicals.

• Bachelor’s Degree in Chemistry, Biology, or another Life Science discipline.
• At least 5 years of experience in a GLP or cGMP analytical laboratory environment.

• Understanding of 21 CFR Part 11, 210 and 211, and ICH Q7.
• Excellent written and verbal communication skills, good documentation practices and attention to detail.
• Knowledge and understanding of analytical chemistry techniques listed above (HPLC, GC, KF, DSC, TGA, IR, MS, NMR, LC‑MS).
• Experience reviewing GMP technical data from the listed analytical techniques.
• Adequate technical writing skills to author reports, training memos and operating procedures.

Pay Range
: $70,000 – $109,200. The offer range represents the anticipated low and high end of the base pay compensation for this position. Compensation will be determined by location, level of experience, education, skills, and other factors. Position may be eligible for sales or performance-based bonuses. Benefits include health insurance, paid time off (PTO), retirement contributions and other perquisites.

What we offer: We are committed to creating access and opportunities for all to develop and grow at their own pace. Join us in building a culture of inclusion and belonging that empowers everyone to work their magic and champion human progress.