QC Material Management Specialist We are currently looking to recruit a QC Material Management Analyst to join the QC Site Operations team at its Multi-Product Cell Culture Drug Substance Facility in Dublin.
Reporting to the QC Material Management Supervisor, they will be responsible for supporting site activities related to the Sample Management/Buffer Preparation Laboratory, in-process samples, and laboratory duties in accordance with cGMP regulations.
Main ResponsibilitiesLiaise with manufacturing to ensure all Drug Substance samples are processed and delivered to the appropriate destination in an appropriate timeframe.Liaise with Engineering Stores to ensure all Drug Product samples are processed and delivered to the appropriate destination in an appropriate timeframe.Liaise with Warehouse Cryogenics Logistics (WCL) to ensure all Raw Material samples are processed and delivered to the appropriate destination in an appropriate timeframe.Manage TempTales and shipping documents when receiving samples from external sites.Log in of samples to LIMS/CIMS or logbooks, and label accordingly.Release samples for QC testing.Storage of backups and reserve samples.Perform monthly reconciliation and report deviations to Sample Management Lead, if any.Aliquot samples for the QC activities for Global Biologics Laboratory and Multi Product Cell Culture (MPCC) Facility.Buffer preparation activities for the QC Laboratories.Generate and update SOPs and other relevant documents as required.Maintain a high standard of GMP compliance including the completion and provision of training as required.Keep abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.Perform any other activities as indicated by the Lab Supervisor.The successful candidate must demonstrate excellent written and verbal communication skills and the ability to work in a team-based collaborative environment.
The ideal candidate should hold a minimum of a third-level qualification (Degree) in Chemistry/Biology or related discipline.
#J-18808-Ljbffr