Provide technical support for routine data integration & reviewing activities of raw materials, finished product, bulk in-process and component documentation. Identify basic technical problems, atypical test results or methodology data integration and assist in the investigation to correct them. Remediate complicated technical issues related complexity of data. Other important duties include ensuring notebooks and reports are in compliance with regulatory guidelines, completing projects data review within time limits and, verifying mathematical calculations, interpreting results, recording observations and responding to and assisting in audits and investigations. Participate in departmental training and provide guidance to junior staff members.
Accurately review data using validated test methods and SOPs in a cGMP environment. Demonstrate technical competence in the data review that is related analytical data integration. Review methods that is related to use of instrumentation & data processing to the job including: IR Infra-Red Spectroscopy UV/Vis Ultra Violet/Visible Spectroscopy GC Gas Chromatography HPLC High Pressure Liquid Chromatography UPLC Ultra High Pressure Liquid Chromatography AA Atomic Absorption Spectroscopy Dissolution apparatus Compendial testing (USP, Ph Eur, JP, FCC) ex. Monograph assay, limits tests, chemical and physical tests Responsible for analyzing data, maintaining accurate and detailed written records and notebooks and thoroughly reviewing lab notebooks ensuring compliance to test methods and specifications. Ability to work in a team environment. Other duties as assigned such as TrackWise deviation initiation.
Bachelor's Degree (BA or BS) in Chemistry, Biology or related science required. A minimum of 5 years of relevant experience in the pharmaceutical industry; or equivalent combination of education and experience.