QC Analyst LIMS

The LIMS Project Analyst is responsible for ensuring that the effective deployment of LIMS Labware V8 on site, aligned with industry best practices and to meet company expectations. This includes proactively developing, implementing, LIMS Master data to support manufacture, testing, and release of products.

Key Responsibilities:

• Configuration or modification of LIMS setups, including microbiology or QC Analytical methods, product specifications, schedulers, standards & reagents, COA's, Label and printer setup, and associated LIMS Master Data.
• Creation and verification of LIMS Master Data as required.
• Development of Test Scripts/Test Protocols for formal LIMS test execution as required.
• Execution of informal and formal verification testing of the configured LIMS solution in collaboration with Computer Systems Validation (CSV) project resources.
• Hosting facilitated review workshops with users to walk them through the configured LIMS, making updates prior to design completion and testing.
• Supporting end users in terms of training materials and execution, troubleshooting during hyper-care stages, and escalating issues to IT or LIMS Administrators.
• Contribute to the development of LIMS Configuration/Design Specifications and Design Note documentation.
• Assisting with LIMS Hardware setup in collaboration with DD&T.
• Analysing user requirements and LIMS design in collaboration with business users and associated team members.
• Configuration of interfaces between LIMS and Analytical Equipment or associated software, and interfaces to SAP where required.
• Collaborating with various stakeholders, including business/QA/QC/Manufacturing, Project Manager, Labware technical SMEs, and in-house LIMS Administrators.
• Leading or coordinating identified elements of the LIMS project stream, including task management, stakeholder follow-ups, supplier follow-ups, and issue escalation.
• Undertaking other LIMS-related tasks assigned by the Project Lead/Project Manager.

Education & Experience required:

• Bachelor's degree in a life sciences, IT or a related scientific discipline.
• A minimum of 1 years LIMs administration / Master Data Building experience within a GMP environment.
• Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas. Specific experience in cell therapy is an advantage.
• Thorough understanding of quality systems and cGMP's.

HYBRID working available