<p>SUMMARY:</p> <p>Analytical Chemist I perform routine and non-routine analytical quality control analysis of raw materials, in-process, finished products and stability samples with compliance to GMPs and corporate standards and adhering to regulatory requirements.</p> <p>RESPONSIBILITIES:</p> <ul> <li>Accurately performs testing per compendia or vendor methodology on raw materials and in-process, finished product, and stability testing per specifications and within procedural and regulatory requirements. </li><li>Work with laboratory instruments including but not limited to HPLC, GC, FTIR, UV-Vis, pH meter, and Karl Fischer. </li><li>Read, understand, and follow standard operating procedures (SOPs) raw material specifications, validation instructions, test sheets, and company policies and processes. </li><li>Write or review SOPs, methods, laboratory investigations, equipment, and software IQOQs. </li><li>Document laboratory work in accordance with cGMP and regulatory standards and a high level of integrity and accuracy. </li><li>Perform data review on daily calibration checks, equipment maintenance, and solution preparations. </li><li>Train new Analytical Chemist I on methods and instrumentation. </li><li>All other tasks as requested or assigned. </li></ul> <p>QUALIFICATIONS AND REQUIREMENTS:</p> <ul> <li>Bachelor's degree in chemistry or related field. </li><li>Experience and knowledge of HPLC, GC, AAS and Wet Chemistry procedures, etc. required. </li><li>Knowledge of Laboratory systems for Reference Standards, Chemical Inventory, Calibrations, Volumetric Solution Preparation and Expiration, Notebook documentation standard, calculations and reporting standards required. </li><li>1+ years' experience in pharmaceutical and/or cGMP laboratory preferred. </li><li>Proficiency in Microsoft Office Suite (Word, Excel, and Outlook) required. </li><li>Detailed-oriented with high level of accuracy and integrity in laboratory testing and documentation. </li></ul>