LGC’s Clinical Diagnostics Business Unit 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, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include Technopath Clinical Diagnostics, which is highly regarded as a leader in the IVD industry, having developed a first-of-its-kind range of consolidated immunochemistry quality control products, The Native Antigen Company, which is a manufacturer and supplier of antigens and antibodies, which are key components in vaccine research, and for the accurate diagnosis of a wide range of infectious diseases, SeraCare Life Sciences and Maine Standards, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials). Our 450+ employees operate an ISO 9001-accredited facility in Tipperary (Ireland), Oxford (UK), and FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA.

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.

The successful candidate will be able to demonstrate the following behaviours in line with LGC’s Core Values:

• Passion: Pride in our achievements engenders passion for our work and it translates into our ambition to make the world a safer place.
• Curiosity: We constantly look forward to what's next: our curiosity for today's discoveries makes tomorrow's innovations possible.
• Integrity: A commitment to high ethical standards has been at the heart of LGC since we started testing the integrity of products in 1842.
• Brilliance: We strive to be the very best in everything we say and do. We exceed customers' expectations through innovation and pioneering science.
• Respect: We respect gender, age, nationality, religion and individuality – our diversity is our strength.

Role and Responsibilities:

• Conducting validation and verification activities to support the introduction of an electronic system to generate ‘Instructions for Use’
• Generation, reviewing and release of ‘Customer facing documentation’ (i.e. Instruction for Use, XML generation, webpage maintenance etc.)

• Instructions for use
• XML files
• Rilibäk Guidelines
• Kit & Vial Labelling

• Control, distribution and administration of labelling documentation, which support Technopath’s quality management systems.
• Support Labelling team in ensuring that relevant labelling requirement standards are met at Technopath
• Process and approve labelling related document change requests
• Support tasks to deliver for CE marking activities as required to IVD directive & IVD Regulation.
• Provide support to Technopath Manufacturing QA, R&D Quality and Quality Systems areas from a quality perspective as required.
• Other duties as required to support Technopath quality systems
• 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.
• Performs other related duties as assigned by management.
• Support the Technical Library activities and review on a daily basis.
• Support the Labelling Specialist in preparing Labelling documentation on time.

Qualifications:

• Minimum Level 5 qualification in a relevant Science, Pharmaceutical, Engineering or Quality Assurance discipline

or

• 1+ years industry experience working in a regulated medical product environment would be advantageous.
• Good knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDD2017/746/EU, In Vitro Diagnostic Medical Device Regulation EU/2017/746 and international regulatory requirements
• Strong interpersonal skills and the ability to communicate well – verbally and in writing – with others.
• Excellent attention to detail and ability to prioritise
• An ability to manage a number of jobs at the same time.
• Knowledge of InDesign advantageous