Quality Control Scientist

Work Location:

Madison, Wisconsin

Shift:
Department: LS-SC-UYWQFB QC Release, VOA
Hiring Manager:
Abel Madrigal

This information is for internals only. Please do not share outside of the organization.

Your Role:

The Scientist, Quality position is responsible for the cGMP analytical laboratory analysis review in the Quality Control department of Millipore Sigma. 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.

Who You Are

Minimum Qualifications:

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

Preferred Qualifications:

• 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.

Pay Range for this position: $70,000-$109,200

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

For more information .

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.

Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.