Quality Control Analyst

Associate Scientist

Summit, NJ

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 guidance of a supervisor or designee. Responsibilities will include, but are not limited to, the following: Clinical release and stability testing, method validation support, reference standards qualification. Able 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 testing. Conducts routine analytical experiments using analytical methods and procedures such as finished products and API Assay, Related impurities and Dissolution testing. Draws basic conclusions from data and results and communicates with other analysts and management. Performs instrument/method troubleshooting within analytical method parameters and management guidance (If needed for confirmatory or investigational testing). Performs testing for development, release and stability samples in accordance with established methods, specifications and protocols with limited supervision. Good laboratory documentation skills. Strictly following cGMP in reference to testing and documentation requirements. Documents/reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with cGMP requirements.

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 team environment to achieve results. Exhibits sound scientific judgment based on reasonable assumptions and available information.

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