barxxxxxx - Qc Supervisor Job Profile in Parsippany, NJ

• 10 Years of Bioanalytical Leadership: A seasoned professional with over a decade of experience in bioanalytical studies, demonstrating a strong track record in stability studies, team leadership, and ensuring cGMP compliance. • Regulatory & Method Development Expert: Highly proficient in ICH, US FDA, EU, and CHP Guidelines, specializing in QbD-based analytical method development, validation, and method transfers across various dosage forms. • Comprehensive Technical Skills: Adept at operating and maintaining a wide range of analytical instruments, including, UV Spectrophotometers, Karl Fischer Titrators, Mettler Toledo equipment, Osmometers, and Satorius systems. • Proven Leadership & Compliance Oversight: Skilled in leading QC and AR&D teams, conducting thorough OOS/OOT and incident investigations, managing critical documentation (SOPs, STPs, Change Controls), and enforcing strict GLP and GMP requirements. • Extensive Stability Program Management: Experienced in overseeing all aspects of drug stability studies and forced degradation, including the preparation of detailed stability summary reports. • ERP and inventory ordering for the lab requirements