Join LGC as a Manufacturing Quality Assurance Specialist in the scenic town of Tipperary, Ireland. Become part of a highly motivated team committed to delivering perfect quality in all we do. If you have a passion for quality assurance and want to work alongside top professionals, this role is for you!

Job Responsibilities

• Perform batch record review to release raw materials, components, and finished devices.
• Review and approve protocols, reports, and documentation updates ensuring adherence to Technopath Clinical Diagnostics (TCD) procedures/policies and regulatory requirements.
• Ensure accurate use of statistical QA methods in the production environment.
• Apply quality tools to monitor and analyze quality performance. Identify important opportunities for improvement. Ensure all process developments follow the Quality Management System.
• Implement quality systems and detailed approaches across Technopath Manufacturing businesses.
• Ensure adherence to all detailed Quality Management System requirements, as per ISO13485, MDSAP, IVDD, IVDR, and FDA.
• Conduct internal audits as needed to verify that TCD’s quality management system meets the requirements of ISO13485, MDSAP, IVDD, IVDR, and FDA.
• Offer training on processes as needed to ensure adherence to the quality management system.
• Ensure adherence to internal procedures and regulatory requirements for the secure handling, storage, documentation, and accountability of controlled drugs, as applicable to the role.
• Maintain a high level of housekeeping in designated areas and observe all Health and Safety at work requirements.
• Provide assistance to other departments within Manufacturing Quality Assurance when required