Document Control Administrator

Posted 7 Days Ago
Be an Early Applicant
Tipperary
Junior
Food • Healthtech • Biotech
The Role
The Document Control Administrator manages quality documentation, document changes, and raw material specifications while ensuring compliance with regulations.
Summary Generated by Built In

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.
  • Performs 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

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

Top Skills

Fda 21Cfr820
Iso13485
Ivdd98/79/Ec
Ivdr Eu/2017/746
Quality Management Systems
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The Company
Teddington
1,459 Employees
On-site Workplace

What We Do

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality and range.

LGC’s tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimise food production; and continuously monitor and enhance the quality of food, the environment and consumer products.

LGC’s 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community.

LGC’s core purpose of Science for a safer world and its core values of passion, curiosity, integrity, brilliance and respect, drive its culture. As of 30 June 2021, it employs 4,350 employees, of which over 1,175 employees hold PhD and/or master’s degrees. Its products and services are delivered by highly qualified and experienced teams, operating from a global network of accredited sites that showcase its scientific and manufacturing capabilities.

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