QC Specialist - Material Management
Location: Dublin, Ireland ( Onsite)
Contract Duration: End of the year (31/12/2026) with possibility of extension.
Step into a high-impact role at the heart of a leading biologics site, where your expertise in sample coordination and GMP operations will directly support the release of life-saving therapies.
Key Responsibilities
- Coordinate and manage the end-to-end lifecycle of samples across Drug Substance, Drug Product, and Raw Materials
- Liaise with Manufacturing, Engineering Stores, and Warehouse teams to ensure samples are processed and delivered within required timelines
- Log, track, and label samples using LIMS/CIMS and controlled documentation systems
- Prepare samples for QC testing, including reconstitution and aliquoting for global laboratory activities
- Manage incoming shipments, including TempTales and associated shipping documentation
- Support Drug Product Stability programmes, including sample enrolment and timepoint pulls
- Maintain storage of backup and reserve samples in line with GMP requirements
- Perform monthly reconciliations and report any deviations or discrepancies
- Support buffer preparation activities within QC laboratories
- Generate and update SOPs and relevant GMP documentation
- Contribute to continuous improvement initiatives across the QC function
- Ensure full compliance with GMP, data integrity, and regulatory standards
Qualifications, Knowledge & Skills
- Degree (BSc or higher) in Life Sciences, Chemistry, or a related discipline
- Experience in QC, sample management, or laboratory operations within a GMP-regulated environment
- Strong working knowledge of LIMS/CIMS and GMP documentation practices
- Exposure to biologics manufacturing, stability studies, or sample lifecycle management is highly desirable
- Understanding of data integrity principles (ALCOA+) and regulatory expectations
- Strong organisational skills with the ability to manage multiple priorities in a fast-paced environment
- Excellent communication skills and ability to work cross-functionally
We're actively shortlisting - Apply now or get in touch today to avoid missing out!
