QC Analytical Scientist

Job description

Your mission The QC Analytical Scientist is responsible for the testing of gene therapy products and associated materials used for manufacturing to EU and FDA GMP requirements. Job Description: Major Activities: - The testing of gene therapy products in accordance with product specifications to ensure all testing is completed within the required timelines in alignment with the production schedule. - Support testing requirements for the management of the facility including support of the environmental monitoring schedule. - Operation and maintenance of laboratory equipment ensuring all equipment is calibrated and suitable for use in alignment with the test schedule. - Record of out of specifications, non-conformances, investigations, analysis and implementation of corrective action(s) as applicable. - Assistance with the development and updating of SOPs and laboratory documentation. - Part of the Quality Control team, maintain the flow of information, ensuring appropriate communications are passed and information folders are maintained with most recent version/communication. - Ensure all training is undertaken in a timely manner as required to perform required activities. Support an...