Quality Control Analyst

Responsible for assisting with laboratory analysis for clinical release and clinical stability testing. Conduct reference standards qualification analyses of developmental and commercial compounds, prototype formulations, and finished products in support of clinical testing for NDA submissions. Participate in validation, clinical testing, and technical transfer analysis. Perform laboratory analysis under the guidance of a supervisor or designee.Responsibilities will include, but are not limited to, the following:Clinical release and stability testingMethod validation supportReference standards qualificationAble to conduct testing independently and may assist other analysts in analytical testing including HPLC, UPLC, GC analysis, dissolution, Karl Fischer, UV/Vis, and other analytical laboratory testingConduct routine analytical experiments using analytical methods and procedures such as finished products and API Assay, Related impurities, and Dissolution testingDraw basic conclusions from data and results and communicate with other analysts and managementPerform instrument/method troubleshooting within analytical method parameters and management guidance (if needed for confirmatory or investigational testing)Perform testing for development, release, and stability samples in accordance with established methods, specifications, and protocols with limited supervisionGood laboratory documentation skillsStrictly following cGMP in reference to testing and documentation requirementsDocument/review laboratory work using laboratory notebooks/worksheets that is detailed, timely, and in compliance with cGMP requirementsQualifications

BS/MS in analytical chemistry or relevant discipline with equivalent experience. Minimum 2 - 4 years recent cGMP pharmaceutical laboratory experience. Experience with HPLC, UPLC, dissolution, FT-IR, UV/Vis spectrophotometry, KF, etc. Good communication skills. Able to work well in a team environment to achieve results. Exhibits sound scientific judgment based on reasonable assumptions and available information.

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