23 days ago
The QC Material Management Analyst will be joining 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 Sample Management 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
* 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 and preferably with at least 1 year of experience in a pharmaceutical / healthcare laboratory or related technical function.
The Next Step for you:
Interested in this role? Please send your CV to Raquel Lourenco at Next Generation Recruitment by clicking on the Apply button!
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