Associate Quality Assurance Pharmaceutical Filling

Come and join the CSL Behring Quality team based in Broadmeadows (Australia) as a Quality Assurance Associate.  We have TWO positions available, one is an ongoing role and the other is a fixed term position until July 31 2025.  In these roles you will ensure the appropriate quality of systems and processes, review compliance with  any applicable CSL standards and procedures, and you will review and approve related records.  In addition, you will support quality risk assessments, non-conformances, investigations, CAPAs, change controls, and the monitoring and continuous improvement of quality performance metrics. Specifically, will gain valuable technical knowledge as you support the Filling Value Stream.
 

Reporting to Associate Director, Value Stream Quality Lead - Filling, in this onsite role you will:

• Oversee all production and support related activities.

• In situ (GEMBA) oversight within the clean rooms (Grade B gowning qualification is required) and post event oversight (footage review) for media filling 

• Oversight of the media visual inspection process;

• Perform initial risk assessments for atypical events within the process (deviations);

• Complete in-process checks, sampling and inspection for AQL processes;

• Ensure the appropriate review and approval of related quality records (procedures, batch records);

• Support quality risk assessments, non-conformances, investigations, CAPAs and change controls;

• Support monitoring and continuous improvement of quality performance metrics.

To be considered for this role you have:

• Bachelor’s Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience;

• Minimum of three (3) years working in a similar role in GMP environment;

• Experience working as part of a team in a large scale, fast paced environment.

• Understanding of, or experience in Aseptic pharmaceutical manufacturing and technical support, Pharmaceutical Quality and compliance, health authority expectations and inspections, and the manufacture and packaging of blood products.

Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-222324 by 12 February 2024.
 

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