CHEMIST III

Chemist III serves as a senior member of the Analytical Laboratory team, providing technical expertise in analytical testing, method development, method validation, and laboratory investigations within a cGMP-regulated environment. This role supports laboratory operations through advanced analytical techniques including HPLC, GC, AA, and other instrumental methods. It also serves as a technical mentor to junior personnel and ensures compliance with FDA regulations, GMP, GLP, and internal quality standards. Responsibilities include performing analytical testing of raw materials, in-process and finished products; operating and maintaining analytical instrumentation (HPLC, GC, AA, FTIR, pH, viscosity, specific gravity); documenting results in line with GMP and data integrity requirements; supporting investigations related to OOS/OOT and deviations; leading method development, transfer, verification, and validation; authoring validation protocols, reports, and test methods; ensuring methods comply with USP, FDA, ICH, and internal requirements; participating in equipment qualification and calibration; assisting with audits and inspections; providing technical guidance and mentoring to Chemist I/II; driving continuous improvement in efficiency, robustness, and compliance; maintaining reagent inventories and SDS/PPE standards; performing other duties as assigned.