Position Summary: The Analytical Chemist conducts analytical testing on raw materials, longitudinal and accelerated stability, in-process, finished bulk, and finished products. Responsibilities include designing and implementing new processes, validations, and instrumentation as required. Testing is performed in compliance with cGMP, supporting the Analytical Lab management in maintaining a high-quality laboratory environment. Responsibilities Prepare samples for testing on raw materials, in-process, and finished products. Physical and chemical testing in accordance with standard procedures, utilizing wet-chemistry and instrumental techniques. Operation and maintenance of scientific instruments including but not limited to HPLC, GC-FID, GCMS, TOC, EDX, UV-vis, and FTIR. Perform daily/monthly instrument calibrations to ensure all instruments are working properly. Write, review, and execute validations of assay methods. Maintain accurate, up-to-date and concise laboratory notebooks and records. Work closely as a team to complete all required tasks in a timely manner. Monitor product quality to ensure compliance to standards and specifications. Understand and precisely follow Standard Operating Procedures, global methods, local methods and published standard or compendia methods i.e. USP, ISO, ASTM. Understand and apply basic laboratory safety instructions, reagent handling precautions, and disposal of chemical waste according to local environmental regulations. Communicate with other departments regarding production, stability, and other business goals. Participate in/lead OOS investigations and other issues encountered in the analytical lab. Troubleshoot and perform maintenance on instrumentation as needed. Work with Shimadzu instrumentation provider to gain more training and knowledge of instrumentation. Participate in the maintenance and calibration of instrumentation via third-party vendors. Maintain inventory of required equipment and consumables. Train new and existing personnel on current SOPs and analytical techniques. Mentor lab technicians and newer staff members. Write SOPs for new and/or improving processes. A technical resource for annual SOP review.
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Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees