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Greater San Diego Area United States

Sr. Manager, Quality Assurance - CMC at Intercept Pharmaceuticals

Medical / Health Care / Pharmaceuticals

Accomplished Quality Control / Quality Systems Professional in the pharmaceutical industry with a formal education in analytical chemistry and experience in pharmaceutical analysis, stability program and laboratory management, technology transfer, quality systems, manufacturing documentation, product release, and internal / external auditing. •Over 15 years experience in a cGMP (21 CFR Part 210 and 211) environment ensuring safety, identity, strength, purity, and quality; •Five years as a manager of laboratory staff ranging from 9-13 people; •Over nine years managing QC/Stability programs for commercial product and clinical trial materials; •Diverse analytical skills ranging from ba