Bristol Myers Squibb is seeking a QC Sample Management Specialist to join the QC Materials team at its Multi-Product Cell Culture Drug Substance Facility in Cruiserath, Dublin. The successful candidate will support site activities related to the Sample Management Laboratory, in-process samples, stability samples, retains and laboratory duties in accordance with cGMP regulations.
Requirements
- 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.
- Logging 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 Manager, if any.
- Reconstitute and Aliquot samples for the QC activities for Global Biologics Laboratory, Global Stability and Multi Product Cell Culture (MPCC) Facility.
- Support buffer preparation for the QC Separations lab
- Support enrolment of bulk Drug Product Stability Study Samples
- Support timepoint pulls of Drug Product Stability Study Samples
- 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.
Benefits
- Competitive salary
- Annual bonus
- Pension contribution
- Family health insurance
- 27 days annual leave
- Access to BMS Cruiserath on-site gym
- Life assurance