Senior Associate Quality Assurance Value Stream Filling

We are looking for an experienced Senior Associate Quality Assurance (QA) to join the CSL Behring Quality team based at Broadmeadows (Australia) on a fixed term basis until 30 June 2025. Reporting to Associate Director, Value Stream Quality Lead - Filling, you will provide quality oversight to the filling and associated activities by assuring appropriate quality of systems and processes and adherence to applicable CSL standards and procedures. You will review and approve related records, including quality risk assessments, non-conformances, investigations, CAPAs, and change controls, and you will encourage the continuous improvement of quality performance metrics.

Based onsite at Broadmeadows and working with a diverse team, you will:

• Partner with the Operational Services group in Filling to manage deviation processes including supporting root cause analysis and development and agreement of robust CAPAs and analysis of repeat issues.
• Coach and mentor investigation management across Operational Services Value Streams. Coach and mentor in peer review across the Value Streams.
• Partner with the Operational Services Value Stream to ensure deviations are closed within lead times to meet the batch release schedule and ensure consistent supply of product to patients, and meet global KPI requirements
• Manage change controls by recording information in a comprehensive way and ensuring that planned implementation actions are appropriate and supported by relevant level of risk statements.
• Participate in internal inspections and regulatory inspections to support compliance requirements;
• Develop, manage and deliver training on systems and processes to Value Stream production partners as required.
• Represent QA Value Stream Filling through Tiered accountability and escalation processes and on local and global projects and by serving on steering committees as required.
• Work with other Quality teams across the network in Filling to improve and standardise the quality processes and standards.

To be considered for this role you have:

• A Bachelor's Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience;
• 5+ years' experience working in a similar role in pharmaceutical manufacturing or other regulated manufacturing industry;
• 3+ years experience working with GxP and local and international regulatory requirements i.e. TGA and FDA;
• Experience making risk based quality decisions with relevant justifications;
• Experience in TrackWise or Veeva and electronic document management systems (eDMSs);

Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-227349 by 28 May 2024.

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