Join to apply for the Document Control Administrator role at LGC Clinical Diagnostics.
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.
We're seeking a Document Control Administrator to maintain our Quality Documentation.
Job Description
* Control, distribution, and administration of Quality documentation, which support Technopath’s quality management systems.
* Process and approve document change requests followed by providing notification of changes to controlled documents to relevant parties.
* Maintenance of various logs associated with tracking of documentation or tasks.
* Incoming Quality Assurance: Maintain raw material specifications (file/update), complete check of raw material certificates of analysis, perform visual inspections.
* Perform batch record review.
* Support Technopath Internal Audit program.
* Perform other related duties as assigned by management.
* Demonstrate an understanding of the application of the Quality Policy through daily activities. Maintain vigilance to ensure adherence to the policy and system procedures by promptly reporting noncompliance issues to management.
Qualifications
* Minimum of degree qualification in a relevant Science, Engineering or QA subject area.
* 2+ years industry experience working in a regulated environment for medical devices.
* Basic knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDR EU/2017/746 and international regulatory requirements.
* Excellent communication skills and attention to detail.
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!
Seniority level
Not Applicable
Employment type
Full-time
Job function
Administrative
Industries
Biotechnology
#J-18808-Ljbffr