Quality Control Associate Scientist

Merck • Madison, WI

1d • Onsite

About The Position

The Madison overnight shift Scientist, Quality Associate 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, reference standard requalification, 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 position has 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, Biology or other Life Science discipline
• 1 year in a GLP or cGMP analytical laboratory environment
• External applicants must be eligible to work in the US

Nice To Haves

• 2+ years of experience in a GMP manufacturing or testing laboratory
• Understanding of 21 CFR Part 11, 210 and 211, and ICH Q7
• Experience with chemical analyses including HPLC, GC, KF, IR, MS, and NMR
• Excellent written and verbal communication skills
• Good documentation practices and attention to detail
• Knowledge and understanding of analytical chemistry techniques

Responsibilities

• cGMP analytical laboratory analysis in the Quality Control department
• Incoming raw material analysis
• In-process testing
• Final product analysis
• Method validation/qualification
• Cleaning
• Reference standard requalification
• Environmental monitoring to support Quality Control activities at the Madison and Verona sites
• Initiation and review of deviations, OOS/OOT’s, change controls, and CAPA’s
• Participation in process improvement initiatives
• Working in a team environment
• Maintaining a clean and safe work area
• Supporting the department in maintaining the laboratory in an audit ready state
• Assisting in many areas beyond specific job duties

Benefits

• health insurance
• paid time off (PTO)
• retirement contributions
• other perquisites

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level