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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 31 July 2025 (maternity leave replacement). Reporting to the Manager QA Value Stream Release, you will review batches of intermediate, semi-finished and finished product and authorise their release. You will also help review quality issues related to post-release actions including Product Technical Complaints (PTC) and Adverse Event Investigations (AE).

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

• Review the relevant product portfolio batch / release documentation to ensure that intermediates and final product are suitable for further processing or release and report any issues identified;
• Perform detailed review of batch records for starting materials, intermediate and final products;
• Perform batch dispositions of plasma, intermediates, and semi-finished including completing SAP transactions and preparing documentation required;
• Coordinate PTC investigations and Adverse events to identify the root-cause and appropriate corrective and preventive actions;
• Participate in internal inspections and regulatory inspections to support compliance requirements;
• Perform SAP master data management for QA release;
• Provide training to value stream production partners;
• Work with other Quality teams across the network in Batch Release 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-by 19 May 2024.

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