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Manager, Quality Control
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- Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates.
- This person additionally will have responsibilities to actively manage data and document by using various software like Excel, istability, JMP, and Veeva for clinical and commercial projects.
- The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
- Perform QC review/approval of analytical test data for IPC testing, drug substance/product batch release and stability test data.
- Manage stability activities at CDMOs and compile/analyze stability data/reports using istability and JMP and maintain a reference standard and critical reagent programs
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