Document Control Specialist

Posted 2 Days Ago
Be an Early Applicant
Tipperary, IRL
Hybrid
Mid level
Food • Healthtech • Biotech
The Role
Manage and close document control notifications (DCNs), train staff on DCN processes, maintain document control metrics, perform internal quality audits, and ensure compliance with FDA QSR, ISO 13485 and relevant regulatory requirements to support the quality management system.
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.

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!

#lgcij

Skills Required

  • B.Sc in Science, Engineering, QA, or related field, or equivalent experience
  • Minimum of 3 years practical experience in a quality function
  • Knowledge of FDA 21CFR820 (QSR), ISO 13485:2016, IVDD98/79/EC and IVDR/EU/2017/746
  • Excellent communication skills and strong attention to detail
  • Strong initiative and troubleshooting skills

LGC Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about LGC and has not been reviewed or approved by LGC.

  • Healthcare Strength Health, dental, and vision coverage with FSA/HSA options are consistently part of the package, and private medical is cited where applicable in the UK. Coverage is often characterized as solid alongside other core benefits.
  • Retirement Support Retirement offerings include a 401(k) with employer contribution in the U.S. and pension schemes in the UK, complemented by life and disability insurance. These elements are highlighted as part of a standard-to-competitive core package.
  • Leave & Time Off Breadth Paid time off, holidays, sick leave, and family leave are broadly available, with some sites offering a year‑end shutdown. Flexibility and local leave programs contribute to a generally well-rounded time‑off offering.

LGC Insights

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The Company
HQ: Teddington
1,459 Employees

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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