The Opportunity

We are looking for a Senior Associate, Operational Servicesin our manufacturing Broadmeadows site. Reporting to Manager Operational Services Visual Inspection and Packing, you will manage the implementation of routine changes in response to manufacturing value stream priorities and provides expertise in the facilitation and analysis of minor deviation investigations within manufacturing.

This exciting role is a 12-month fixed term opportunity.

The Role

Change Management

• Lead cross functional task completion of routine changes with short- and long-term time frames on existing and new processes, following standard operating procedures and standardized processes.
• Partner with the manufacturing direct operations SME's to understand the problem statement or opportunity so as to reliably represent the change across the business and enable the direct manufacturing SME to meet the S&O plan.
• Set the charter and scope in conjunction with the manufacturing direct SME's.
• Plan and communicate the change, ensuring all stakeholders progress the tasks to completion.

• Investigate deviations of any criticality from within the manufacturing area.
• Collaborate with QA and manufacturing to understand the scope and circumstances of the deviation.
• Assemble in conjunction with the direct manufacturing team's information to enable QA to assess risk at SQuIPP impact meetings to meet procedural timeframes.
• Assemble an investigation team and lead the investigation to closure. Manage all documentation from investigation initiation to completion.
• Review and verify the accuracy and completeness of the investigation.
• Communicate investigation and conclusions to key stakeholders and completes any further status updates in collaboration with the QA approver.

• Tertiary Qualification in Sciences or Engineering.
• 5+ years of experience (R&D, Tech Services, Quality or Manufacturing) in a pharmaceutical, biotechnology, or biological industry.
• Demonstrated understanding of cGMP, regulatory requirements and relevant environmental, health and safety requirements as applicable to secondary manufacturing.
• A team player with demonstrated initiative and proven problem solving, communication skills.