Manufacturing Quality Assurance Specialist

About LGC Clinical Diagnostics

LGC Clinical Diagnostics creates and produces both standard and custom diagnostic quality solutions and component materials for the wider life sciences sector. The company works with IVD assay developers, pharmaceutical organizations, CROs, and academic institutions to support commercialization across the full diagnostic workflow. Its products are relied on in clinical chemistry, immunochemistry, serology, and molecular diagnostics to help deliver accurate results.

The business is supported by experienced scientific teams, efficient operations, and robust quality systems that enable advanced technologies every day and contribute to better patient outcomes.

Role overview

LGC is hiring a Manufacturing Quality Assurance Specialist for its site in Tipperary, County Tipperary, Ireland. This is a full-time, onsite opportunity for someone who is motivated by quality, enjoys working with skilled professionals, and wants to help uphold high standards across manufacturing and compliance activities.

Key responsibilities

• Carry out batch record checks to authorize the release of raw materials, components, and finished devices.
• Examine and approve protocols, reports, and document revisions while making sure they align with Technopath Clinical Diagnostics procedures, policies, and regulatory obligations.
• Use statistical quality assurance methods correctly within the production setting.
• Apply quality tools to track and assess quality performance, and spot meaningful areas for improvement.
• Support the rollout of process improvements in line with the Quality Management System.
• Help implement quality systems and structured approaches across Technopath Manufacturing operations.
• Maintain compliance with Quality Management System requirements, including ISO13485, MDSAP, IVDD, IVDR, and FDA expectations.
• Perform internal audits when required to confirm that the quality management system meets ISO13485, MDSAP, IVDD, IVDR, and FDA standards.
• Deliver process training where needed to strengthen compliance with the quality management system.
• Follow internal procedures and regulatory rules for the safe handling, storage, documentation, and control of controlled drugs where the role requires it.
• Keep assigned work areas clean and orderly, and follow all health and safety requirements.
• Support other Manufacturing Quality Assurance functions whenever needed.

Requirements

• A B.Sc. in Science, Engineering, Quality Assurance, or a related discipline, or equivalent practical experience.
• At least 3 years of hands-on experience in a quality-related role.
• Working knowledge of FDA 21CFR820, ISO13485:2016, IVDD 98/79/EC, IVDR EU 2017/746, and other international regulatory requirements.
• Strong written and verbal communication skills, along with close attention to detail.
• Ability to work independently as well as collaboratively within a team.
• Good troubleshooting and problem-solving ability.

Benefits and additional information

• 25 days of annual leave.
• Life assurance and a health allowance.
• Discounts with local and national retailers.
• Access to a free 24/7 Employee Assistance Programme.
• Recognition initiatives and monetary awards.

Values and workplace culture

LGC highlights five core values: passion, curiosity, integrity, brilliance, and respect. The company says it promotes inclusion and collaboration, and it welcomes applications from people of all backgrounds. It is an equal opportunity employer and provides reasonable accommodations for candidates with disabilities. If adjustments are needed during recruitment, candidates are encouraged to let the employer know.

What the role offers

This position is described as challenging, rewarding, and impactful, with the chance to contribute meaningfully to quality assurance within a global organization focused on advancing the industry.

Location

Tipperary, County Tipperary, Ireland.