Senior Associate Quality Control Scientist

Merck•Verona, WI

About The Position

The Sr Associate QC Scientist position is responsible for the cGMP analytical laboratory analysis 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 XRPD 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 position will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.

Requirements

Bachelor’s Degree in Chemistry, Biochemistry 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
Ability to work in analytical testing lab with hazardous and toxic chemicals

Responsibilities

Conduct analytical testing of cGMP materials (samples, reference standards) and ensure data accuracy using proper techniques and documentation.
Assist with training new laboratory staff and perform peer reviews.
Maintain a safe, audit-ready, and clean lab; manage general housekeeping and waste disposal.
Maintain laboratory supplies and equipment: ordering reagents, ensuring clean glassware, and routine upkeep.
Solve data-driven problems with evaluation of identifiable factors, exercising judgment within defined procedures.
Manage projects and timelines with minimal oversight; coordinate with internal groups to keep activities on track.
Perform instrument Performance Verifications (PV) and manage change controls/CAPAs to ensure on-time completion.
Support OOS/OOT investigations, SOP writing/revision (raw material, intermediate, final product specs, stability protocols) and ensure compliance with ICH Q7 and 21 CFR parts 11, 210, 211; uphold data integrity.