Quality Control Scientist

Merck•Verona, WI

1d•Onsite

About The Position

The Scientist, Quality position is responsible for validating methods and technical transfers as well as providing technical and analytical leadership to the Quality Control department at Millipore Sigma. Analysis involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. The position demonstrates the ability to work on, and solve, problems independently with some guidance. Other responsibilities may include initiation and review of deviations, OOS/OOT’s, change controls, and CAPA’s. Additionally, participation in process improvement initiatives, and working in a team environment. In this role, you will contribute to the overall success of the company by assisting in many areas beyond specific job duties. Perform method validations, transfers and analytical testing of cGMP materials; ensure data accuracy with proper techniques and documentation. Conduct and contribute to peer review of analytical data (e.g., HPLC, KF, GC) to ensure quality. Train new or less experienced personnel on SOPs, analytical methods, and instrument operation. Maintain a safe, audit-ready, and clean lab environment with rigorous data integrity. Manage lab upkeep: order reagents, ensure clean glassware, dispose of waste properly, and perform general housekeeping. Tackle complex data-analysis problems; apply critical thinking and lead root-cause analysis in OOS/OOT investigations with corrective/preventive actions. Perform instrument PVs and OQs; coordinate with internal and external groups to keep projects on track. Author and revise SOPs and specifications (raw materials to stability); ensure compliance with ICH Q7 and 21 CFR Parts 11/210/211; support right-first-time data integrity.

Requirements

Bachelor’s Degree in Chemistry, Chemical Engineering, or other Life Science discipline.
5+ years of experience in a GLP or cGMP analytical laboratory environment.

Nice To Haves

Experience with method validation.
Experience as a project lead.
Experience with team and client interactions.
Experience with technical writing skills to author operating procedures, protocols and reports.
Knowledge and understanding of organic analytical chemistry.

Responsibilities

Perform method validations, transfers and analytical testing of cGMP materials; ensure data accuracy with proper techniques and documentation.
Conduct and contribute to peer review of analytical data (e.g., HPLC, KF, GC) to ensure quality.
Train new or less experienced personnel on SOPs, analytical methods, and instrument operation.
Maintain a safe, audit-ready, and clean lab environment with rigorous data integrity.
Manage lab upkeep: order reagents, ensure clean glassware, dispose of waste properly, and perform general housekeeping.
Tackle complex data-analysis problems; apply critical thinking and lead root-cause analysis in OOS/OOT investigations with corrective/preventive actions.
Perform instrument PVs and OQs; coordinate with internal and external groups to keep projects on track.
Author and revise SOPs and specifications (raw materials to stability); ensure compliance with ICH Q7 and 21 CFR Parts 11/210/211; support right-first-time data integrity.