Reporting directly to the Quality Manager, the Quality Associate is responsible for performing the Quality review of batch records for products produced at Repligen Waterford. Additional responsibilities will include, but not limited to, managing the batch review and batch release process, supporting the timely turnaround of documentation review, generation of certificates of conformance, and supporting manufacturing operations as required.

• 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.

• 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.

Required Education:

• Desirable that the candidate possess a 3rd level qualification in a related discipline or is working towards.

Related Categories:

• Quality Assurance / cGMP / ISO 9001 / ISO 13485

• Private Medical Insurance for candidate, spouse and dependants under 18 years old
• Company pension contribution 5% matched
• Serious Illness Income protection 75% of base salary (after 13 weeks)
• Life Insurance x 4 time annual salary
• Company and personal performance related bonus plan/structure
• Continuous Professional Development supported through Training & Development