Axolabs→
Document Control Specialist at Axolabs · Tipperary
Skills
Job 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, a world-class leader in scientific research and diagnostics, as a Document Control Specialist! Located in the beautiful Tipperary, Ireland, this is an outstanding opportunity to contribute to our innovative projects and ensure our documentation processes are flawless!
Key Responsibilities
- Perform document control notification (DCN) closure according to procedural requirements.
- Ensure DCN’s are completed according to the timelines requested by departments across Technopath Clinical Diagnostics.
- Provide training and continued support on the DCN process for new and existing employees as required.
- Maintain and communicate metrics relating to document control process.
- Conduct internal quality system audits as per annual audit schedule.
- Ensure compliance with all detailed 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.
- Additional responsibilities as needed to assist Technopath Clinical Diagnostics quality management system.
Qualifications
Qualifications
- B.Sc in Science, Engineering, QA, or a related field, or equivalent experience.
- 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
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!
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