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Quality Assurance Associate, Analytical
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- Catalent Pharma Solutions in San Diego, CA is hiring a Quality Assurance (QA) Associate, Analytical.
- The QA Associate must be familiar with applicable GMP. This individual will be responsible for evaluating the compliance of manufacturing and analytical documents such as test methods, batch records, stability and release data, etc.
- We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing as well as Clinical Supply Services.
- 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.
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