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Quality Assurance Associate, Analytical
Location:
Abee
Description:
Job Title: Quality Assurance Associate, Analytical City: San Diego State : CA JOB DESCRIPTION : 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. Review and approve controlled documents including protocols, test methods, master batch records, and specifications for analytical testing. Lead role in onboarding new compounds to the site involving review of toxicology data and performing a nitrosamine backssment to ensure the risks of a new compound are considered against site capabilities. Perform internal and external audits. Lead or support client audits along with the Director and Associate Director of Quality Assurance Manage a direct report and train the direct report on analytical data review of stability and release data. Perform Line Clearance activities to ensure the correct equipment and materials have been staged in the manufacturing suite before the production begins. Perform the release, quarantine and rejection of raw materials used in the production of samples and approve the respective specification of raw materials. Review calibration, validation and preventative maintenance. Visit ListedBuy for more information.
Company:
Catalent
Posted:
April 27 on ListedBuy
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More About this Listing: Quality Assurance Associate, Analytical
Quality Assurance Associate, Analytical is a Quality Assurance QA Job at Catalent located in United States. Find other listings like Quality Assurance Associate, Analytical by searching Oodle for Quality Assurance QA Jobs.
Quality Assurance Associate, Analytical is a Quality Assurance QA Job at Catalent located in United States. Find other listings like Quality Assurance Associate, Analytical by searching Oodle for Quality Assurance QA Jobs.