Quality Associate

BS3; City of Greater Dandenong; Sur place; AUD 42 000 - 59 000; Temps partiel

Résumé du poste

BS3 is seeking a part-time Quality Associate to support the Quality Manager in audits, deviations, CAPAs and training. You will influence day-to-day quality operations to ensure compliance with GDP/GWP standards within a pharmaceutical and medical warehouse.

The role focuses on controlled documents, investigations, logbooks, training, and continuous improvement, with emphasis on safety and regulatory adherence across BS3 operations.

Qualifications

• At least 4 years of 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 elevate compliance concerns.
• Experience with controlled drugs and cold chain (highly regarded).

Responsabilités

• 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, 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

Connaissances

GDP/GWP knowledge

cGMP certification

Good Documentation Practice

Strong writing skills

Training others

Quality investigations

Description du poste

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.

The Quality Associate plays a critical role in ensuring the safe, accurate, and compliant handling of regulated pharmaceutical, healthcare, and controlled products within the warehouse. The role directly supports product integrity and regulatory compliance across all BS3 operations while meeting customer expectations in a timely and accurate manner.

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 Good 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 elevate compliance concerns

Experience with controlled drugs and cold chain (highly regarded)

Requirements

A clear National Police Check, renewed annually

A part-time role with real impact on quality and compliance

Meaningful work that gets medicines and medical supplies where they’re needed