Quality Control Associate Scientist

About the role

The 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.

Responsibilities

• Analysis of incoming raw materials, in-process testing, final product analysis, method validation/qualification, cleaning, reference standard requalification, and environmental monitoring
• Initiation and review of deviations, OOS/OOT’s, change controls, and CAPA’s
• Participation in process improvement initiatives
• Maintaining a clean and safe work area
• Supporting the department in maintaining the laboratory in an audit ready state

Requirements

• Bachelor’s Degree in Chemistry, Biology or other Life Science discipline
• 1 year in a GLP or cGMP analytical laboratory environment

Qualifications

• 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 and good documentation practices and attention to detail
• Knowledge and understanding of analytical chemistry techniques

Skills

• Strong analytical skills
• Attention to detail
• Good documentation practices
• Ability to work independently and as part of a team

Benefits

• Health insurance
• Paid time off (PTO)
• Retirement contributions

Pay

$27.00-$46.00 per hour

Schedule

Shift is 10pm-8am Monday (night)-Friday (morning)