Document Control Specialist

at  LGC Clinical Diagnostics

ABOUT LGC CLINICAL DIAGNOSTICS:

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 commercialization activities across the entire diagnostic pipeline. 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 Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is 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), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US.
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.
Job Description
To ensure all documentation within the Quality Management System is introduced, updated and maintained in a controlled manner in compliance with the Document Control Procedure and ISO13485:2016.

Qualifications

• B.Sc. in Science/Engineering/QA or related discipline.
• A minimum of 3 years practical experience required 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.
• Strong initiative and troubleshooting skills required

• Perform document control notification (DCN) closure in line with procedural requirements.
• Ensure DCN’s are closed in line with timelines required by departments across Technopath Clinical Diagnostics.
• Provide training on the DCN process for new and existing employees as required.
• Provide support on the DCN process for all trained employees.
• Maintain and communicate metrics relating to document control process.
• Conduct internal quality system audits as per annual audit schedule
• Ensure compliance with all documented Quality system requirements, as per FDA QSR’s and ISO 13485:2016
• Maintain a good level of housekeeping in designated areas and observe all Health and Safety requirements.
• Other duties as required to support Technopath Clinical Diagnostics quality management system.

Qualifications

• B.Sc. in Science/Engineering/QA or related discipline.
• A minimum of 3 years practical experience required 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.
• Strong initiative and troubleshooting skills required.

Additional Information