Sr Associate Quality Scientist - Data Reviewer

Merck•Madison, WI

8d•$26 - $46

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 Associate Senior (Data Reviewer) 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, 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. The Scientist, Quality Associate Senior (Data Reviewer) position will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties. Perform analytical data reviews of cGMP data to ensure accuracy and quality using ALCOA+ principles. Analyze complex problems requiring in-depth evaluation of various factors. Exercise judgment to select techniques, methods, and evaluation criteria for data analysis. Investigate deviations, identify root causes, and propose corrective/preventive actions with minimal assistance. Maintain laboratory operations by managing supplies, ensuring cleanliness, and proper waste disposal. Manage change controls and CAPAs to ensure timely completion. Collaborate within the QC department and with other departments to achieve project goals. Support method development, validation, and routine QC analysis while ensuring compliance with 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.
3+ 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

Perform analytical data reviews of cGMP data to ensure accuracy and quality using ALCOA+ principles.
Analyze complex problems requiring in-depth evaluation of various factors.
Exercise judgment to select techniques, methods, and evaluation criteria for data analysis.
Investigate deviations, identify root causes, and propose corrective/preventive actions with minimal assistance.
Maintain laboratory operations by managing supplies, ensuring cleanliness, and proper waste disposal.
Manage change controls and CAPAs to ensure timely completion.
Collaborate within the QC department and with other departments to achieve project goals.
Support method development, validation, and routine QC analysis while ensuring compliance with regulatory standards.