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Senior Quality Assurance Associate

Job description

The Opportunity
An established, highly regulated manufacturing organisation is seeking a Senior Operational Services Associate to support critical manufacturing operations within a complex production environment. This role plays a key part in deviation management, change management, and cross-functional collaboration, helping ensure manufacturing activities remain compliant, efficient, and continuously improving.
You’ll work closely with Manufacturing, Quality, and Technical teams, acting as a subject matter expert across investigations, CAPAs, and GxP change initiatives.

Key Responsibilities
  • Lead and manage deviation investigations across manufacturing operations
  • Facilitate root cause analysis and drive investigations through to closure
  • Develop, manage, and track CAPAs, ensuring timely completion
  • Partner with Quality and Manufacturing teams to assess risk and impact
  • Coordinate and lead GxP change management activities
  • Support cross-functional projects and operational improvements
  • Monitor investigation and change metrics, escalating risks where required
  • Maintain strong documentation standards in line with regulatory requirements
About You
You’ll be a confident operator in regulated manufacturing environments, comfortable working across multiple stakeholders and priorities.

You will bring:
  • A tertiary qualification in Science or Engineering
  • 5–10 years’ experience in pharmaceutical, biotechnology, or biological manufacturing
  • Experience in deviation investigations, CAPA management, and change management
  • Strong understanding of GxP environments
  • Solid communication and stakeholder engagement skills
  • The ability to manage timelines, priorities, and competing demands
Why Apply?
  • Join a well-established, values-driven organisation
  • Work in a highly technical, regulated environment with real impact
  • Be part of a collaborative team supporting critical manufacturing outcomes
How to Apply
If you’re looking to step into a senior operational role within regulated manufacturing, we’d love to hear from you.

Please contact Jo Turner, Divisional Manager on 0488 807 377 for a confidential discussion or APPLY NOW