Quality Engineer

Job description

Overview 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. Responsibilities: - 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 responsibili...