A fantastic career opportunity for an eager Science graduate with GMP lab experience from an internship or someone working within a QC Sample Management role that wants to gain exposure to sample management in a large biopharmaceutical company. 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.
*12 month contract.*
Responsibilities will 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.
Qualifications & Experience:
- Hold a minimum of a third level qualification (Degree) in Chemistry/Biology or related discipline.
- 1 - 2 years' work experience/internship/placement in a pharmaceutical / healthcare laboratory or related technical function.
- Knowledge of GMP regulations.
- Previous experience in a sample management role required.
