Description
Profile: Experienced Analytical Chemist * Self-motivated, result driven, detail oriented individual, works well as a team member or independently, willingness to learn * Strong background in GMP/GLP, analytical and wet chemistry * Well-versed in USP, EP and JP policies and procedures, chemical hygiene and safety policies * Analysis and release of raw materials, finished products, in process, and stability samples * Method development of multiple Active Pharmaceutical Ingredients (APIs) in various dosage forms * Write and execute analytical validations protocols for FDA compliance * Write, review and approve SOPs and change controls * Investigations of deviations, and out of specification results, performed CAPAs * Operation of laboratory instrumentation including but not limited to UHPLC, HPLC, GC, Chromatography software, UV/VIS, IR, Polarimeter, Karl Fisher, Titroprocessor, Dissolution, computer programs (Excel, word processing)