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Quality Assurance Associate, Analytical
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- Review of analytical release and stability data, involving review of Potency tests of investigational new tablets and capsules using High Performance Liquid Chromatography (HPLC) or Ultra Performance Liquid Chromatography, Water Content using Karl Fischer Titration and Karl Fischer Oven, physical characterization of crystalline and partially crystalline solids using tests like Powder X-Ray Diffraction (PXRD), Thermogravimetric analyzer (TGA) and Differential Scanning Calorimeter (DSC).
- Review Hardness testing and Friability of tablets, Content Uniformity and Blend Uniformity using HPLC, Dissolution of tablets and capsules using UPLC or UV-Vis Spectroscopy, testing for Residual Solvents using Gas Chromatography (GC) and Microbial Enumeration Testing (MET) of samples using Empower 3 for HPLC and UPLC, Tiamo for the Karl Fischer Oven, Miniflex Guidance for PXRD, and the Trios Guardian Software for TGA and DSC.
- Lead role in onboarding new compounds to the site involving review of toxicology data and performing a nitrosamine assessment to ensure the risks of a new compound are considered against site capabilities.
- Manage a direct report and train the direct report on analytical data review of stability and release data.
- Reviewing of analytical release and stability data, involving review of Potency tests of investigational new tablets and capsules using High Performance Liquid Chromatography (HPLC) or Ultra Performance Liquid Chromatography, Water Content using Karl Fischer Titration and Karl Fischer Oven, physical characterization of crystalline and partially crystalline solids using tests like Powder X-Ray Diffraction (PXRD), Thermogravimetric analyzer (TGA) and Differential Scanning Calorimeter (DSC).
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