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Pharmaceutical Stability Chemist 

EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
Full-Time/Part-Time Full-Time  

The Stability Program leader role requires prior experience in a regulated environment with an understanding of product stability requirements (in particular, FDA and EU). The individual should have experience with Quality System documentation (i.e. reading/following/writing SOPs, writing protocols and reports. investigation writing).

Essential Functions

  • Lead the Stability Program for drug and cosmetic products.
  • Prepare Stability Protocols that meet regulatory (FDA & ICH) requirements and customer expectations.
  • Ensure that required stability samples are collected from production, placed on stability under appropriate conditions, pulled at the required time, and promptly testing against protocol specifications.
  • Coordinate and oversee outside storage and testing of samples when required.
  • Review, summarize, and interpret stability data for inclusion in Stability Reports and Annual Product Reviews.
  • Prepare final Stability Reports for review and approval.
  • Leads and/or coordinates review meetings related to the
  • Stability Program.
  • Monitor onsite stability chambers to ensure internal conditions meet regulatory requirements.
  • Drive effort to establish a stand-alone Stability Program as part of the strategic plan.
  • Serve as a back-up for the Product Data Analyst in the preparation of Annual Product Reviews. Assist in cross training the Product Data Analyst in critical aspects of the Stability Program.
  • Perform other projects and assignments as requested by Management.
Location Port Washington, WI  

This position is currently accepting applications.

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