Manufacturing Quality Assurance Specialist at LGC Group

Tipperary, The Municipal District of Cahir — Cashel, Ireland -

Full Time

Start Date

Immediate

Expiry Date

05 Oct, 26

Salary

0.0

Posted On

07 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Batch Record Review, Quality Assurance, Statistical QA Methods, Internal Auditing, ISO 13485, MDSAP, IVDD, IVDR, FDA 21CFR820, Troubleshooting, Communication Skills, Attention To Detail

Industry

Biotechnology Research

Description

Company Description LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, pharmaceutical, CRO and academic institutions in commercialisation activities across the entire diagnostic pipeline. Professionals in clinical chemistry, immunochemistry, serology, and molecular diagnostics rely on LGC's products for accurate diagnostic results. Our exceptional team, scientific expertise, efficient operations, and quality systems support a range of advanced technologies daily, improving patient outcomes. Job Description 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 Qualifications B.Sc. in Science, Engineering, QA, or a related field or equivalent experience. A minimum of 3 years of practical experience in a quality function. Knowledge of FDA 21CFR820, ISO13485:2016, IVDD98/79/EC, IVDR/EU/2017/746, and international regulatory requirements. Excellent communication skills and attention to detail. Ability to work on own initiative and within a team. Strong troubleshooting skills. Be part of a team where your contributions make a significant impact, and work in a role that offers both challenge and reward. Here at LGC, we value collaboration, proven expertise, and the drive to compete on a global scale. Successfully implement your skills and determine the future of quality assurance with us! Additional Information Our values PASSION CURIOSITY INTEGRITY BRILLIANCE RESPECT Benefits Join us and enjoy: 25 days holidays Life assurance & health allowance Discounts with local and national retailers Free 24/7 Employee Assistance Programme Recognition schemes and monetary awards At LGC, we foster a culture of inclusion and collaboration. We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply. We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities. If you require any adjustments throughout the recruitment process, please let us know. Join us in this outstanding opportunity to be part of a company that is leading advancements in the industry! #lgcij Work Arrangement: Hybrid Department: Quality Assurance and Regulatory Affairs

Responsibilities

The role involves performing batch record reviews and ensuring adherence to quality management systems and regulatory requirements. It also includes conducting internal audits and implementing quality tools to monitor performance and identify improvements.