Quality Control Analyst Ii
Current- Conducted routine analysis of In-Process, release and stability testing of pharmaceutical products, standards and controls validation, plus method development and validation- Utilized multiple LC techniques to quantitate % fragmentation, pI determination, endotoxin content and aggregate-to-monomer levels of monoclonal antibody therapeutics- Used GDP to hand record data and assay performance contemporaneously in GMP certified lab notebooks, using detail and explanations for future reference and traceability- Compiled data into assay reports and coordinated with peer-reviewers, QA and senior scientists to finalize and submit completed records according to established QA regulations and related SOP’s - Implemented LEAN/5S principles towards lab organization: sorting and ordering lab materials and reagents, maintaining Controlled and non-controlled inventory, optimizing lab space and work flow and encouraging teammates to contribute and maintain- Assisted with OOS investigations and deviation reporting, environmental and bioburden monitoring, clean room air sampling, routine cleaning and maintenance, calibrations and IQ/OQ/PQ of equipment