Your Role

The Quality Assurance (QA) Associate, Bulk and Recombinant Value Stream assures the appropriate quality of systems and processes adherence to applicable CSL standards and procedures.

In this role you will review and approve records, support quality risk assessments, non-conformances, investigations, CAPAs, and change controls in addition to monitoring and continuous improvement of quality performance metrics.

Your Responsibilities

Reporting to the Manager, Quality Assurance you will:

• Be responsible for product quality and compliance, partnering with all teams within the site value streams regarding product quality aspects
• Oversee all production and support related activities to provide real time (GEMBA) and post event (CCIT) review of process steps, media filling and visual inspection oversight, documentation, activities and behaviour
• Complete in-process checks, sampling and inspection for AQL processes
• Provide quality guidance and point of contact for escalations
• Perform QA review and approval of operational, processing and records to ensure regulatory compliance with Australian, EU and USA regulatory requirements, as defined in relevant CSL procedures
• Provide technical input to the process of deviation/events in addition to root cause analysis, development and agreement of robust CAPAs
• Assessment and escalation of identified issues to ensure review is completed to meet batch release timelines

• A minimum of a Bachelor Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience
• At least three (3) years working in a similar role
• Experience in Operational pharmaceutical manufacturing, technical support and manufacturing, Pharmaceutical Quality and compliance.
• Capable of making quality decisions, with coaching from peers, based on risk and provide sound advice and justification
• Proficient in the use of the Microsoft Office suit including Outlook, Word, Visio and
• Excel and electronic document management systems (eDMSs).
• Strong interpersonal, organisational and analytical skills and able to negotiate outcomes with multiple stakeholders
• Demonstrated ability to problem solve by applying advanced technical knowledge and experience