Quality Assurance Administrator at LGC Group

Ireland, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

04 Jan, 26

Salary

0.0

Posted On

06 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Documentation Control, Regulatory Compliance, FDA Regulations, ISO Standards, Attention to Detail, Communication Skills, Batch Record Review, Internal Audits, Visual Inspections, Raw Material Specifications, Change Management, Quality Policy Adherence, Log Maintenance, Scientific Expertise, Manufacturing Quality

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. We're seeking a Quality Assurance Administrator to join our Manufacturing Quality Assurance team. Job Description Control, distribution, and administration of Quality documentation, which support Technopath’s quality management systems. Process and approve document change requests followed by providing notification of changes to controlled documents to relevant parties. Maintenance of various logs associated with tracking of documentation or tasks. Incoming Quality Assurance: Maintain raw material specifications (file/update), complete check of raw material certificates of analysis, perform visual inspections. Perform batch record review. Support Technopath Internal Audit program. Performs other related duties as assigned by management. Demonstrate an understanding of the application of the Quality Policy through daily activities. Maintain vigilance to ensure adherence to the Quality Policy and system procedures by promptly reporting noncompliance issues to management. Qualifications Minimum of degree qualification in a relevant Science, Engineering or QA discipline 2+ years industry experience working in a regulated environment for medical devices Basic knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDR EU/2017/746 and international regulatory requirements Excellent communication skills and attention to detail 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

Responsibilities

The Quality Assurance Administrator will control, distribute, and administer quality documentation supporting the quality management systems. They will also maintain logs, perform inspections, and support the internal audit program.