Quality Control Senior Associate Scientist Friday-Sunday 6:30am-7:00pm
About The Position
The Madison 4th shift Scientist, Quality Associate Senior position is responsible for cGMP analytical laboratory analysis in the Quality Control department of MilliporeSigma. 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 have 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 experience in a GLP or cGMP environment.
Nice To Haves
- 4+ years of experience in a GMP analytical 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
- cGMP analytical laboratory analysis in the Quality Control department
- Incoming raw material analysis
- In-process testing
- Final product analysis
- Method validation/qualification
- Cleaning and environmental monitoring
- 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
