QA R&D Chemist I

QA R&D Analytical Chemist I supports QC and Analytical R&D activities by initiating change controls and updating specifications to reflect method changes. Responsibilities include method improvements, transfers, verifications, residual solvent, elemental impurity and nitrosamine risk assessments, and authoring related reports; performs testing of raw materials, IP, FP and ST samples using HPLC/UPLC/GC/UV-Vis/IR, dissolution, and other USP procedures in a regulated lab; collaborates with R&D on analytical method transfers and troubleshooting; maintains instrumentation, adheres to GMP/GDP, and prepares SOPs and documentation. Requires a Bachelor's degree in Chemistry or related field with 3 years of cGMP lab experience or a Master's degree with 1 year of cGMP lab experience; experience with analytical instrumentation (UV, IR, HPLC, UPLC, GC, dissolution) and familiarity with FDA/ICH guidelines is preferred; located in Monmouth Junction, NJ; full-time role with relocation not offered.