Technician Quality On The Floor Pharmaceutical

CSL Behring Broadmeadows manufactures a comprehensive portfolio of 15 plasma products for Australia from plasma collected by the Lifeblood Australia. Part of the CSL family, when you join the over 1200 employees at Broadmeadows, you join an integrated global network of research and manufacturing facilities delivering on our 100-year-old promise to save lives using the latest technology.

We are looking for a technician to join the Quality Assurance (QA) Value Stream Visual Inspection and Packing on an ongoing basis. Based on-site and working on the manufacturing floor, you will assure that systems and processes follow CSL standards and procedures, review batch documentation records and perform sample inspections. You will also conduct in-process checks and support risk assessments investigations, CAPAs and change controls

Reporting to the Senior Manager QA Value Stream, you will:

• Provide quality oversight to the manufacturing process including oversight of media fill inspections and conduct GEMBA of Visual inspection and packing processes
• Perform the timely QA review of operational. process and other records to ensure compliance with regulatory requirements and CSL procedures including those required for batch disposition.
• Assess and escalate any issues identified to ensure minimal impact on batch release timelines.
• Partner with the Operational Services group within the Value Stream to participate in deviation investigations and help develop CAPAs.
• Work with the Quality on the Floor (QoF) SME to contribute to minor change controls.
• Support continuous improvement activities through training, collaboration and imitative.
• Maintain metrics for activities performed and meet all site and global KPIs.

To be considered for this role you have:

• Degree in science, engineering or equivalent and minimum of two (2) years' experience in a manufacturing, engineering, QA or QA role; Or if no degree 8 years' experience in pharmaceutical manufacturing
• Experience in pharmaceutical manufacturing, technical support, specifically the manufacture and/or packaging of pharmaceutical products
• Understanding of the regulatory aspects of pharmaceutical quality and compliance with regulatory requirements
• Understanding of Quality Risk management principles
• Proficient in document management with experience in a role requiring accuracy
• Experience in a role requiring collaboration to negotiate outcomes and resolve problems.

Please apply with your resume and covering letter, which must address the selection criteria above, and include the reference number R-228973 by April 5, 2024.

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