Based in our Waterford site and Reporting directly to the Quality Manager, the Quality Engineer will act as a Quality point of contact for systems, processes and quality activities within the site and to support the implementation and continuous improvement of quality systems in compliance with US and International regulations, laws and guidelines.

• Review manufacturing orders generated at Repligen Waterford in accordance with procedure.
• Complete batch release and generate certificates of conformance.
• Resolve or communicate risks that may impact the timely review of documentation and delivery of product to the customer.
• Manage the archiving of manufacturing orders and scanning copies to a secure location.
• Verify product labels prior to issuing to manufacturing.
• Generation and tracking of metrics related to right first time for documentation and drive improvement efforts.
• Communicate good documentation practice (GDP) and drive a culture of accurate record keeping in accordance with procedure.
• Lead and participate in quality investigations.
• Support the Quality function, related processes, and business interests of Repligen. The responsibilities of this role may evolve as the organization matures.

• A 3rd level qualification in a related discipline of Quality Assurance / cGMP / ISO 9001 / ISO 13485
• Have prior experience with the enforcement of good documentation practice (GDP).
• Attention to detail is critical in this role related to documentation review and generation of certificates.
• The candidate must be well organised and be able to coordinate with manufacturing and delivery schedules.
• Candidates must possess good communication and interpersonal skills to work in interdisciplinary teams.

• Private Medical Insurance 
• Company pension 
• Serious Illness Income protection
• Life Insurance
• Company and personal performance related bonus plan/structure
• Continuous Professional Development supported through Training & Development