Quality Systems Specialist

LGC Limited; Ballina; On-site; EUR 52,000 - 72,000; Full time

Benefits offered by this job

25 days holidays

Life assurance & health allowance

Discounts with retailers

24/7 Employee Assistance Programme

Job summary

LGC Clinical Diagnostics, Ballina, is seeking a Quality Systems Specialist to join the QA team. This role supports the maintenance and improvement of the site’s quality systems, including supplier qualification, supplier audits, CAPA, and document control. It offers an opportunity for career growth within a global life sciences company.

The successful candidate will have a B.Sc. in a science/engineering/QA discipline, at least 2 years in quality, and strong knowledge of FDA 21 CFR 820, ISO

Qualifications

• B.Sc. in Science/Engineering/QA or related discipline.
• Minimum 2 years practical quality experience.
• Knowledge of FDA 21 CFR820, ISO13485, IVDD/IVDR and international regulatory requirements.
• Familiar with ISO 14971.

Responsibilities

• Implement, maintain and improve quality system at Technopath Manufacturing Business.
• Manage control of Economic Operators (Suppliers/Distributors/Importers/Authorized Reps).
• Review and approve new Economic Operators per quality system requirements.
• Develop quality agreements with Economic Operators with Purchasing/Legal.
• Lead internal audits and supplier quality audits as site Lead Auditor.
• Support CAPA, Change Controls and Documentation Control activities.
• Update SOPs and manufacturing documentation; ensure compliance with SOPs.

Skills

QA knowledge

Regulatory compliance

Documentation control

Auditing

Education

B.Sc. in Science/Engineering/QA

Tools

ISO 13485

FDA 21 CFR 820

IVDR (EU) 2017/746

Job description

• Department: Quality Assurance and Regulatory Affairs

Company Description

LGC Clinical Diagnostics develops and manufactures a range of diagnostic quality solutions and component materials for the life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialisation activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is a manufacturer and supplier of viral antigens and LGC Proficiency Testing a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US.

Our exceptional team, scientific skills, operational efficiency, and high-quality systems are primed daily to assist various advanced technologies, benefiting patient outcomes.

Job Description

LGC is a world-class Clinical Diagnostics company committed to improving patient healthcare. We are looking for a motivated and ambitious Quality Systems Specialistto join our growing QA team in Ballina. This is a fantastic opportunity for someone early in their quality career who wants to develop into a future QA Specialist.

To perform this job successfully, an individual must be able to capably perform each of the following essential functions:

Duties:

• Implement, maintain and continuously improve applied quality system approach at Technopath Manufacturing Business.
• Manage process for control of Economic Operators to TCD (Suppliers / Distributors / Importers / Authorised Reps).
• Liaise with the Purchasing & Business Development groups to identify new Economic Operators as needed. Review suitability of new Economic Operators in accordance to established quality system requirements and approve for use if all require criteria have been achieved.
• Collaborate with Purchasing and Legal to ensure the development and implementation of effective quality agreements with Economic Operators.
• Monitor existing Economic Operators’ performance on a routine basis.
• Communicate with Economic Operators regularly. Establish and develop good working relationships with Technopath Economic Operators.
• Support the assessment of non-conforming raw materials received from suppliers. Liaise with Quality Systems to ensure the effective completion of Supplier Corrective Actions (SCAR's)
• Conduct Economic Operator quality control audits as required to ensure vendors and their supplies remain in compliance with company requirements and regulatory standards.
• Support Incoming Quality Assurance: Maintain raw material specifications (file/update), complete check of raw material certificates of analysis, perform visual inspections.
• Coordinate, execute and lead the auditing program by conducting internal audits as well as supplier quality audits as the site Lead Auditor.
• Support and participate in external Audits (HPRA, Notified Body Audit, Customer Audits)
• Provide support to Non-Conformance, CAPA, Change Controls and Documentation Control activities as required.
• Update, review and approval of quality documentation such as SOPs, Material control records, Manufacturing Documentation etc.
• Perform other duties as required to support Technopath Manufacturing Quality Systems (QA, RA, Quality Support)
• Operate within the company’s standard operating procedures and review, maintain and create appropriate procedures.
• Ensure compliance with internal procedures and regulatory requirements for the secure handling, storage, documentation, and accountability of controlled drugs, as applicable to the role.
• Maintain a good level of housekeeping in designated areas and observe all Health and Safety at work requirements.

Qualifications

• B.Sc. in Science/Engineering/QA or related discipline.
• A minimum of 2 years practical experience required in a quality function.
• Thorough knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDR (EU) 2017/746 and international regulatory requirements.
• Familiar with ISO 14971.

Additional Information

LGC is a top life science tools company, offering important solutions in growing markets.

Our values

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT
• 25 days holidays
• Life assurance & health allowance
• Discounts with local and national retailers
• Free 24/7 Employee Assistance Programme
• Recognition schemes and monetary awards
• Great long-term career opportunities

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 unique opportunity to be part of a company that is leading advancements in the industry!