Quality Compliance Associate

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Quality & Compliance Associate at AsureQuality Diagnostics in Melbourne's Tullamarine is a hands-on role to ensure quality and regulatory obligations across Australia and New Zealand. You will support the QMS, inspect and release materials, review batch process sheets, issue batch documents promptly, and help with ISO 9001 and ISO 13485, APVMA, DAFF and BICON compliance, plus manage non-conformances, CAPAs, deviations and change controls, and oversee document control and training systems. Candidates need a Bachelor of Science and 3+ years in quality, regulatory or compliance in GMP manufacturing, strong MS Word/Excel and communication skills; ISO 13485, auditing, or validation experience is highly regarded. To apply, tailor your resume to demonstrate QMS impact, cite concrete CAPA outcomes, emphasize cross-functional collaboration and onsite readiness in Melbourne.

Company Description

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.

Job Description

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

Qualifications

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