Quality Associate – Part‑time Pharmaceutical Warehouse

About the role

We are seeking a part‑time Quality Associate to keep our pharmaceutical and medical warehouse audit‑ready and compliant. You will work closely with the Quality Manager, supporting audits, deviations, CAPAs and training, and have real influence on day‑to‑day quality operations.

Key responsibilities

• 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 Good Documentation Practice.
• Facilitate investigations, root cause analysis and action plans with the operations team.
• Report on close‑out rates and quality trends 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.

Required profile

• 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.
• Clear National Police Check, renewed annually.

Required skills

• GDP/GWP knowledge.
• cGMP compliance.
• ISO 9001:2015 standards.
• CAPA and deviation management.
• Change control processes.
• Internal audit execution.
• Root cause analysis.
• Qualification and validation activities.
• Cold‑chain and controlled‑drug handling (highly regarded).

What we offer

• Part‑time role with real impact on quality and compliance.
• Meaningful work that gets medicines and medical supplies where they’re needed.
• Supportive, collaborative team environment.