Analyst II, QC Raw Materials

Role: On-site laboratory testing specialist supporting quality systems and scientific operations in a biopharma manufacturing environment. Responsibilities include sample testing, raw material release, maintaining lab equipment, executing quality notifications (deviations, CAPAs, Change Controls), and supporting validation and investigations. Ensures compliance with GMP, ISO, FDA, and EU regulations; manages laboratory data via LIMS; and drives continuous improvement using LEAN practices. Requirements: Bachelor's or Master's in applied sciences (preferably chemistry); 3-5 years’ GMP lab experience; proficiency in physical, chemical, and instrumental methods such as FTIR, UV-Vis, HPLC, and Gel Electrophoresis; knowledge of cGMP, CFR, USP; strong documentation and analytical skills; and effective communication. Preferred: GMP manufacturing background with raw material assay experience. High-value: laboratory quality support for biologics or small molecule manufacturing, GMP compliance, validation, deviation investigations, and GxP systems. Work setup: on-site position; physical and mental demands consistent with laboratory work.