Job Summary:
We are seeking a QC Material Management Specialist to join the QC Site Operations team at a multi-product cell culture drug substance facility in Dublin for a 12 month contract. Reporting to the QC Material Management Supervisor, the successful candidate will support sample management and laboratory activities in compliance with cGMP regulations. This role is critical to ensuring the timely, accurate processing and control of samples across manufacturing, warehouse, and QC operations.
Key Responsibilities:
- Liaise with Manufacturing, Engineering Stores, and Warehouse Cryogenics Logistics to ensure timely processing and delivery of Drug Substance, Drug Product, and Raw Material samples
- Manage TempTales and shipping documentation for samples received from external sites
- Log samples into LIMS/CIMS or logbooks and ensure accurate labelling
- Release samples for QC testing and manage storage of backup and reserve samples
- Perform monthly sample reconciliations and report any deviations to the Sample Management Lead
- Aliquot samples to support QC activities for Global Biologics Laboratory and the MPCC facility
- Support buffer preparation for the QC Separations Laboratory
- Generate, review, and update SOPs and other GMP documentation as required
- Maintain a high standard of GMP compliance, including completion of all required training
- Stay up to date with corporate and industry compliance requirements related to laboratory operations and aseptic manufacturing
- Carry out additional duties as assigned by the Lab Supervisor
Key Requirements:
- Minimum third-level qualification (Degree) in Chemistry, Biology, or a related discipline
- At least 1 year’s experience in a pharmaceutical, healthcare laboratory, or related technical role
- Strong knowledge of cGMP principles and laboratory practices
- Excellent written and verbal communication skills
- Ability to work effectively in a team-based, collaborative environment
- Strong attention to detail and organisational skills
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