QC Sample Management Specialist

• Manage shipment of samples externally for analysis.
• Responding to ad-hoc additional sample requests for external labs.
• Administration of documentation with reference to samples, i.e. receipt of external sample results and entry onto gLIMS.
• Reference material inventory management.
• Maintaining all documentation and systems related to their work.
• Generation of Sample Management quality and business-related metrics.
• Point of contact for raw material testing within contract Laboratories
• SME for applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
• Monitor contract laboratory sample/material turnaround times
• Coordinate and document result retrieval from Contract Laboratory facility.
• Review and Verify QC data.
• Generate Material Specification Reports and associated documentation.
• Generate CoA's for raw materials.
• Manage, communicate and document compendia updates as required.
• Author/revise and contributes test methods; SOPs; Material Specification Reports; protocols, technical studies and/or reports.
• Generate SOP's/other documentation as applicable.
• Assist in additional duties as directed by the QC Lab Support supervisor.
• Supports CAPA and change control through participation in project planning and collaboration.
• Ensuring training is up to date.
• Adhering to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
• Ensure that all documentation is carried out on time, accurately and legibly as per GDP and GMP standards.

• Experience of working in cGMP Quality environment (preferable).
• Knowledge of LIMS.
• Knowledge of a Quality Management System e.g. Trackwise.
• Strong organizational and multitasking skills.
• Excellent communication and negotiation abilities.
• Proficient in using procurement software and Microsoft Office Suite.

• A third level qualification in a Scientific Discipline
• Previous hands-on experience with Raw Material assays in a GMP manufacturing environment is preferred.
• Works in a collaborative manner and is able to develop excellent working relationships with peers.
• An understanding of priority setting and time management.
• An understanding of current regulatory requirements for cGMP laboratory operations.
• Good communication skills both internally and externally
• Accuracy and good attention to detail
• Excellent report writing skills.
• Takes a structured, analytical approach to problem solving

Alexion Pharmaceuticals