Quality & Compliance Associate – AsureQuality Diagnostics

Location: Tullamarine, VIC (28 Mareno Road)
Business Unit: Diagnostics
Reports to: Quality Assurance Manager

About the role

We’re looking for a Quality & Compliance Associate to play a key role in ensuring AsureQuality Diagnostics meets all quality and regulatory obligations across Australia, New Zealand and other active markets.

This is a hands-on role suited to someone who enjoys working across a variety of Quality Assurance roles in a regulated diagnostics or medical/veterinary manufacturing environment. The role also provides an opportunity to those with an interest in Regulatory Affairs.

Key responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS)
• QA inspection and release of incoming and raw materials and printed materials. Includes the maintenance of corresponding raw material specifications.
• Review production batch process sheets and final product documentation as part of the product release
• Timely issue of batch process sheets
• Support compliance with the quality management system and certification requirements (e.g. ISO 9001, ISO 13485, APVMA, DAFF, BICON etc.).
• Support the timely assessment and management of product, operational or quality related issues, i.e. product non-conformances, customer complaints, investigations, CAPAs, deviations and change controls.
• Assist with the management and maintenance of the document control and training systems.

About you

• You’re organised, proactive and comfortable working in a regulated environment. You enjoy collaborating across teams and take pride in maintaining high Quality standards.

You’ll bring:

• Bachelor of Science (or equivalent experience)
• 3+ years’ experience in a Quality, regulatory, or compliance role within pharmaceutical, medical device, or veterinary manufacturing
• Experience working in a GMP environment (e.g. TGA, APVMA)
• Experience with Quality Management Systems
• Strong communication and interpersonal skills
• Solid MS Word and Excel capability

Highly regarded:

• ISO 13485 experience
• Experience with biological or diagnostic manufacturing
• Auditor or training qualifications / experience
• Executing validation protocols, including cleaning validations
• Technical writing skills

Why join AsureQuality Diagnostics?

• Work in a leading contract manufacturer and distributor of veterinary and medical diagnostic kits and speciality products
• Be part of a collaborative and dynamic team of experts
• Make a real impact on quality, compliance and continuous improvement

Tertiary Qualification in Science with experience in a GMP Manufacturing environment.