QA Labelling Administrator

Company Description LGC Clinical Diagnostics develops and manufactures a range of diagnostic quality solutions and component materials for the life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialisation activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals rely on LGC’s products to support accurate and reliable diagnostic results. Our operating entities include Maine Standards Company, SeraCare Life Sciences and Technopath Clinical Diagnostics (IVD manufacturers of quality measurement tools), the Native Antigen Company (a manufacturer and supplier of viral antigens) and LGC Proficiency Testing (a global leader in PT schemes). We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA) and Tipperary (Ireland), and ISO 9001-accredited facilities in Oxford (UK) and Michigan (USA). Our exceptional team, scientific skills, operational efficiency, and high-quality systems are primed daily to assist various advanced technologies, benefiting patient outcomes. Job Description Support the Quality Assurance team with the preparation, review and management of labelling documentation for diagnostic products. Key Responsibilities

• Review and approve lot-specific production labels.
• Populate and review Instructions for Use (IFUs) with lot-specific technical data and approve final versions for release.
• Maintain and update IFU templates to ensure technical data is accurate and consistent across products.
• Enter and verify lot-specific technical data in the Technopath Technical Library (XML files).
• Process all labelling updates through the internal document control system.
• Assist with updates to master labelling documents, including labels, packaging specifications and IFUs.
• Help validate changes to IFUs using the electronic auto-population system.
• Upload approved QA labelling files and relevant customer documents to the Technopath Technical Library and website.
• Follow all standard operating procedures and quality system requirements.
• Maintain a clean and safe working environment.
• Carry out other tasks as required by your manager.

Qualifications

• Level 5 qualification in a relevant field such as Science, Pharmaceuticals, Engineering, or Quality Assurance is desirable.
• Ideally 2+ years’ experience working in a regulated medical or diagnostics environment.
• Familiarity with Microsoft Word, Excel, Adobe InDesign and NiceLabel Pro is an advantage.
• Basic understanding of relevant regulatory standards (e.g. FDA 21 CFR Part 820, ISO 13485, IVDD 98/79/EC, IVDR EU 2017/746) would be beneficial.
• Strong written and verbal communication skills, with the ability to work effectively within a team.
• High attention to detail and accuracy in documentation.
• Good organisational skills, with the ability to manage multiple tasks and prioritise effectively.

Additional Information LGC is a top life science tools company, offering important solutions in growing markets. Our values

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

Benefits

• 25 days holidays
• Life assurance & health allowance
• Discounts with local and national retailers
• Free 24/7 Employee Assistance Programme
• Recognition schemes and monetary awards
• Great long-term career opportunities

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 unique opportunity to be part of a company that is leading advancements in the industry! #lgcij