Quality Control Analyst II

Responsibilities: Perform routine and non-routine chemical testing of commercial, validation, and stability samples per written methodology. Conduct qualitative/quantitative analyses using HPLC, GC, UV/Vis, KF, and FTIR. Use LIMS and Empower to acquire/process analytical data. Compare results to approved specifications; notify management of OOS/aberrant results. Participate in root cause problem solving; provide input for CAPA. Maintain lab equipment; perform metrology calibrations and preventative maintenance. Create/maintain GMP lab records; demonstrate “Right First Time.” Maintain clean/safe environment; follow safety procedures. Contribute to continuous improvement, communicate with team/vendors, and participate in daily huddles and 1:1s. Qualifications: Bachelor’s degree required. Minimum 3 years’ experience in a pharmaceutical or similar regulated environment. Skills/Abilities (required): Basic knowledge of USP, cGMP, and FDA regulations. Use Empower and integrated LMS systems. Experience calibrating HPLC/GC systems. Ability to maintain/diagnose/work on lab instrumentation. Also good to have: Prioritize work; troubleshoot methods/instruments; independent work with limited supervision. Benefits (selected): Comprehensive health insurance, 401(k) match, Paid Time Off, company-paid life/disability. #J-18808-Ljbffr