Manage the GMP QC laboratory to ensure that all products are tested for both analytical and microbiological assays, and test results are reviewed and approved for release in accordance with company’s procedures and applicable GMP regulations and guidelines (e.g. 21CFR Parts 11, 210/211, 820, (USP/EP/JP), ICH Guidelines, etc.).
Manage QC’s day-to-day activities which include all aspects of quality control to support release of clinical trial materials and commercial products, as required. This position will interact with cross-functional colleagues from Development, Operations, QA/QC, and Regulatory Affairs departments.
Gas Chromatography (GC) or Thin Layer Chromatography (TLC), considered a plus