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CSL
About the role
We are seeking an experienced and motivated Associate Quality Assurance Fill & VI to join our Global Quality Operations team based in Broadmeadows.
In this role, you will provide end‑to‑end quality oversight for manufacturing and support activities across multiple value streams, ensuring compliance with regulatory requirements, CSL quality standards, and site procedures. You will partner closely with Operations to support product quality, patient safety, and continuous improvement across the site.
This is a hands‑on QA role with strong exposure to manufacturing floor support, deviation management, batch release, change control, and quality systems, making it ideal for QA professionals looking to deepen their operational impact within a regulated pharmaceutical environment.
There are 2 roles. One permanent and the other a fixed term contract until May 2027.
Key Responsibilities
Provide on‑floor and post‑event QA support to manufacturing and support teams.Review and approve batch documentation to support timely batch release.Manage simple/minor deviations and change controls, including investigations and CAPAs.Provide practical, risk‑based quality advice to Operations.Support GMP training, onboarding, and continuous improvement initiatives.Maintain compliance with regulatory requirements (TGA, FDA, EU)
Your Skills And Experience
Bachelor’s degree in science, Engineering, Biotechnology, Pharmaceutical Science or similar3+ years’ experience in pharmaceutical manufacturing or quality assuranceWorking knowledge of GMP, deviations, change control, and batch review.Strong written, organizational, and stakeholder engagement skillsConfidence making quality decisions with a collaborative, solutions‑focused approach.
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