Quality control Analyst I

Qualifications Strong attention to detail and organizational skills Ability to follow instructions and GMP procedures accurately Ability to work independently and manage routine laboratory tasks with minimal supervision Comfortable performing routine and repetitive laboratory and documentation activities Strong time management skills and ability to support multiple priorities simultaneously at least 1–2 years of laboratory experience. (GMP QC laboratory or pharmaceutical industry experience preferred) Previous experience in a fast‑paced GMP QC laboratory environment preferred Basic exposure to HPLC, pH, Density, Osmolality, FT-IR, analytical balances, micropipettes, or analytical laboratory testing strongly preferred Familiarity with ICH, USP, 21CFR Part 210, and 211 preferred Responsibilities Support routine QC laboratory testing using pH, Osmolality, FT-IR, for in-process, finished product, and stability samples testing. Assist with sample management activities including but not limited to sample login, labeling, tracking, storage, and shipment coordination Support stability program execution including sample pulls, submissions, inventory management, and tracking activities Perform accurate documentation and data recording in accordance with cGMP, ALCOA+, and data integrity requirements Maintain laboratory notebooks, worksheets, logbooks, and electronic records in an audit‑ready state Assist with laboratory investigations including OOS results, deviations, invalid assays, and other quality system activities Support laboratory maintenance, calibration, housekeeping, and audit readiness activities Work cross‑functionally with QA, Manufacturing, Stability, Microbiology and external laboratories to support testing timelines and operational priorities Follow approved SOPs, test methods, and other GMP laboratory procedures with minimal supervision Perform self‑review of data and documentation for accuracy and completeness prior to submission for secondary review Adapt quickly to changing priorities, urgent sample requests, and fluctuating laboratory workload #J-18808-Ljbffr AllSTEM Connections