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
We're seeking a Document Control Specialist on an initial 12-month FTC, to ensure all documentation within our Quality Management System is introduced, updated and maintained in a controlled manner in compliance with the Document Control Procedure and ISO13485:2016.
This role is working within our Technopath Clinical Diagnostics business in Fort Henry Business Park, Ballina (Co Tipperary).
Key Responsibilities
* Perform document control notification (DCN) closure according to procedural requirements.
* Ensure DCN's are closed in line with timelines required 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 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
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.
Physical Demands
The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Requires prolonged sitting and working at a computer monitor. Repetitive motion using a keyboard for long periods of time. May occasionally be required to lift and move material weighing up to 10 lbs.
Work Environment
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Agreeable work environment typical of an open office setting with some exposure to noise from office machines.
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
1. Work Arrangement: On-site
2. Department: Quality Assurance and Regulatory Affairs