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.
The main responsibilities for this position include;
• Liaise 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.
• Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
• Performing 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.
