Document Control Specialist

About the Role

LGC Clinical Diagnostics creates and manufactures a wide range of catalogue and custom diagnostic quality products and component materials for the broader life sciences sector. The business works with developers of IVD assays, pharmaceutical companies, CROs, and academic institutions to support commercialisation across the full diagnostic pathway. Its products are used in areas such as clinical chemistry, immunochemistry, serology, and molecular diagnostics, helping professionals achieve reliable diagnostic outcomes.

This role sits with a team known for strong scientific capability, efficient operations, and robust quality systems that support advanced technologies and contribute to better patient results.

Role Overview

LGC is seeking a Document Control Specialist in Tipperary, Ireland, to help ensure document control processes are managed accurately and efficiently within the quality system.

Responsibilities

• Complete document control notification (DCN) closures in line with established procedures.
• Make sure DCNs are finished within the timeframes requested by teams across Technopath Clinical Diagnostics.
• Train and support both new and current employees on the DCN process when needed.
• Track, maintain, and share document control metrics.
• Carry out internal quality system audits according to the annual audit plan.
• Work in accordance with detailed quality system standards, including FDA QSR and ISO 13485:2016 requirements.
• Keep assigned work areas tidy and follow all health and safety rules.
• Take on other duties that support the Technopath Clinical Diagnostics quality management system as required.

Requirements

• A B.Sc. in Science, Engineering, QA, or a closely related discipline, or equivalent practical experience.
• At least 3 years of hands-on experience in a quality-focused role.
• Working knowledge of FDA 21CFR820, ISO 13485:2016, IVDD98/79/EC, IVDR/EU/2017/746, and other international regulatory standards.
• Strong written and verbal communication skills, with excellent attention to detail.
• Self-driven approach and solid problem-solving or troubleshooting ability.

Additional Information

The company’s values are Passion, Curiosity, Integrity, Brilliance, and Respect.

Benefits include 25 days of holiday, life assurance with a health allowance, discounts at local and national retailers, a free 24/7 Employee Assistance Programme, and recognition schemes with monetary awards.

LGC promotes inclusion and collaboration and welcomes applicants from all backgrounds. The company is an equal opportunity employer and can provide reasonable accommodations for individuals with disabilities. Candidates who need adjustments during the recruitment process are encouraged to share that requirement.