Senior Quality Control Associate Scientist

The businesses of Merck KGaA, Darmstadt, Germany•Verona, WI

13h•$26 - $46

About The Position

The Senior Quality Control Associate 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 Biology, Chemistry, Chemical Engineering, or other scientific discipline
1+ years cGMP experience

Nice To Haves

3+ years of experience in a laboratory environment operating under GLP or cGMP conditions
Excellent written, verbal communication skills and excellent documentation practices
Ability to work in a team environment

Responsibilities

Perform analytical testing of cGMP materials (samples, reference standards) and ensure accuracy and quality of data by using proper laboratory techniques and documentation.
Assist with training of newer laboratory staff as needed.
Performs peer review.
Work in a safe manner and ensure the lab stays in an audit ready and clean state.
Maintain the laboratory by ordering reagents or supplies, ensuring clean glassware is available, disposing of waste properly, and completing general housekeeping chores.
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Exercise judgment within generally defined procedures and practices.
Solve problems and make decisions with minimal assistance.
Maintain projects and timelines with minimal oversight.
Meet with internal project groups to keep projects on track.
Perform instrument Performance Verifications (PV) as needed.
Manage assigned change controls and CAPAs to ensure on-time completion.
Participate in OOS and OOT investigations via testing, good documentation, and assisting with identification of root causes.
Assist with writing and revision of SOPs including raw material specifications, intermediate specifications, final product specifications, and stability protocols.
Work cooperatively within the QC department and with other departments to achieve project goals.
Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, and 211 as applicable.
Support all data integrity initiatives and strive for right first time.