Quality Control Scientist

Merck KGaA Darmstadt Germany•Madison, WI

5d•$70,000 - $109,200•Onsite

About The Position

Work Your Magic with us! Start your next chapter and join MilliporeSigma. 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 rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: The Scientist, Quality position is responsible for the cGMP analytical laboratory analysis review in the Quality Control department of MilliporeSigma. Analysis may consist of all/some of the following: 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. Analysis includes techniques specific to, but not limited to: HPLC, GC, KF, DSC, TGA, IR, MS, NMR and LC-MS among other tests and instruments. Other responsibilities may include initiation and review of deviations, OOS/OOT's, change controls, and CAPA's. Additionally, participation in process improvement initiatives, working in a team environment, maintaining a clean and safe work area, and supporting the department in maintaining the laboratory in an audit ready state are other duties. Analyze complex cGMP data using sound scientific rationale 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. Physical Attributes: Work in analytical testing lab with hazardous and toxic chemicals.

Requirements

Bachelors Degree in Chemistry, Biology, or other Life Science discipline.
5+ years experience in a GLP or cGMP analytical laboratory environment

Nice To Haves

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

Responsibilities

cGMP analytical laboratory analysis review
incoming raw material analysis
in-process testing
final product analysis
stability
reference standard requalification
method validation/qualification
cleaning, and environmental monitoring
initiation and review of deviations, OOS/OOT's, change controls, and CAPA's
participation in process improvement initiatives
working in a team environment
maintaining a clean and safe work area
supporting the department in maintaining the laboratory in an audit ready state
Analyze complex cGMP data using sound scientific rationale 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.