2023-935 – QA Specialist – Waterford (Shift) Contractor

This is a 12 month role with a strong view for extension. This is a 2 shift role – (Wk 1: 7am – 3pm Mon – Fri & Wk 2: 3pm – 11pm Mon – Fri)

Purpose

Reporting directly to the Quality Assurance Team Leader, as a critical team member you will play an integral role within Quality Assurance support for Projects. Work as part of the Quality Assurance team on site ensuring projects are manufactured, stored, and tested in accordance with cGMP

Responsibilities

• Provide QA support to new & ongoing projects.
• Review and approval of Change Controls, Deviations, CAPA’s, Protocols, Reports, Quality Events and tasks.
• Acts as Quality Point person for Projects providing guidance / feedback on quality issues
• Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
• Work with relevant departments/project teams to ensure timely closure of quality actions / findings
• Actively contribute to continuous improvement initiatives
• Conduct duties in a safe manner and report all safety issues or concerns

Requirements

• Bachelor’s degree in a science or related discipline
• Experience in Quality Assurance/Projects preferable
• Proven ability to provide quality expertise and support to the QA team and site teams
• Proven ability to support the delivery of tasks in a highly regulated manufacturing environment
• Good communication skills at organization, team, and individual levels
• Knowledge of requirements for cGMP, US, and EU regulatory requirements
• Full understanding of relevant quality and compliance regulations
• Able to manage projects to plan/budget
• Effective facilitator