Associate Scientist, Quality Control at Amneal… · Brookhaven

Summary: Amneal Pharmaceuticals is a company focused on pharmaceutical products, and they are seeking an Associate Scientist for their Quality Control team. The role involves performing testing on raw materials and finished products, ensuring compliance with written procedures and SOPs. Responsibilities: - Performs physical and chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques adhering to company policies as identified in standard operating procedures (SOPs) - Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and other analytical techniques as applicable - Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner - Actively participates in investigation of laboratory results, when required - Assists, as and when needed, scientists working in the laboratory - Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area - Performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC as assigned by the supervisor - Prepares volumetric test solutions following USP or in-house methods for wet chemical tests, standardizes such solutions as required, standardizes API for use as in-house reference standard as assigned Required Qualifications: - Bachelors Degree (BA/BS) Chemistry or related field - Required - less than one year in Testing of chemicals/pharmaceutical products - 1 year or more in Testing of chemicals/pharmaceutical products - Must possess a working knowledge of analytical chemistry techniques, such as analytical weighing, quantitative transfer, preparation of quantitative solutions, analytical dilutions, spectrophotometric analytical techniques, dissolution and drug release, disintegration, moisture determination (Karl Fischer, Coulometric, LOD), thin-layer chromatographic technique, gas chromatographic techniques, HPLC, and measuring physical parameters (bulk and tapped densities, and particle size by sieve analysis) - Must be able to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests - Must understand and apply cGMP requirements applicable to quality control laboratory - This position requires successful completion of an OSHA-compliant Respirator Fit Test Required Skills: Analytical Chemistry Techniques, Analytical Weighing, Quantitative Transfer, Preparation of Quantitative Solutions, Analytical Dilutions, Spectrophotometric Analytical Techniques, Dissolution, Drug Release, Disintegration Testing, Moisture Determination, Thin-Layer Chromatography, Gas Chromatography, High Performance Liquid Chromatography (HPLC), Physical Parameter Measurement, Compendial Procedures (USP/EP/BP/JP), cGMP Compliance, Calibration of Analytical Instruments, Sample Preparation, Laboratory Documentation Benefits: Above-market, diverse and robust health and insurance benefits, Significant 401(k) matching contribution