Quality Control Analyst II

Role: Analytical Laboratory Technician responsible for performing chemical testing of pharmaceuticals to ensure quality and compliance. Responsibilities include routine/non-routine analyses using instrumentation like HPLC, GC, UV/Vis, KF, FTIR, maintaining calibration and qualification of lab equipment, analyzing data against specifications, and participating in root cause investigations and CAPAs. The role requires maintaining GMP-compliant documentation, supporting instrument maintenance, and adhering to safety and regulatory standards. Collaborates with lab team and management to meet testing goals. Qualifications: Bachelor’s degree and at least 3 years of pharmaceutical or regulated environment experience. Skills include knowledge of USP, cGMP, FDA regulations, proficiency with analytical instrumentation, and electronic data systems like LIMS and Empower. Preferred: ability to troubleshoot instruments, work independently, and prioritize tasks. High-value biopharma specifics: focused on pharmaceutical testing, GMP compliance, regulated by FDA, with experience in analytical chemistry and instrumentation calibration. Work setup: not specified.