Senior Quality Control Associate Scientist
About The Position
The Madison 1st shift Scientist, Quality Associate Senior position is responsible for cGMP analytical laboratory analysis in the Quality Control department of MilliporeSigma. Primary responsibilities include oversight of reference standard program and coordination of material requests with internal and external partners. Analysis/review 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, Biology or other Life Science discipline.
- 3+ years in a GLP or cGMP analytical laboratory environment.
Nice To Haves
- 4+ 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, DSC, TGA, IR, MS, NMR, and/or XRPD
- Excellent written and verbal communication skills and good documentation practices and attention to detail
- Knowledge and understanding of analytical chemistry techniques
Responsibilities
- Oversight of reference standard program
- Coordination of material requests with internal and external partners
- Incoming raw material analysis
- In-process testing
- Final product analysis
- Method validation/qualification
- Cleaning and environmental monitoring to support Quality Control activities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
