Want to put your quality expertise to work, with balance? We’re looking for a part-time Quality Associate to help keep a pharmaceutical and medical warehouse audit-ready and compliant. You’ll support our Quality Manager across audits, deviations, CAPAs and training. You’ll also have real influence on how quality runs day to day. If you know GDP/GWP inside out and like turning data into action, we’d like to hear from you.

What You’ll Do
Write and review controlled documents, deviations, CAPAs, customer complaints and change controls to GWP/GDP standards
Flag major or critical risks to the Quality Manager
Conduct internal audits, and support external audits, including agendas, reports and responses
Review logbooks and forms for completeness and Positive Documentation Practice
Facilitate investigations, root cause analysis and action plans with the operations team
Report on close-out rates and quality trends, such as temperature data, at quarterly quality meetings
Train staff in quality procedures, build training materials and manage the training matrix




Help develop and document qualification and validation activities
Onboard contractors on quality and safety requirements
Support continuous improvement across the operation

What you’ll bring
At least 4 years’ experience in the therapeutic goods industry
cGMP, GWP or GDP certification
Working knowledge of the Australian Code of Good Wholesaling Practice and ISO 9001:2015
Experience with deviations, CAPAs, change controls and internal audits
Strong writing skills and attention to detail
Confidence to train others and escalate compliance concerns
Experience with controlled drugs and cold chain (highly regarded)

Requirements
A transparent National Police Check, renewed annually

Why join us
A part time role with real impact on quality and compliance
Meaningful work that gets medicines and medical supplies where they’re needed
A supportive, collaborative team

📌 Quality Associate Melbourne
🏢 Smartways Logistics
📍 Melbourne