Quality - IE_QC Specialist, Material Management

• 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

• 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

Next Generation