Quality Assurance Senior Associate

The Opportunity

Immulab, part of the Paragon Care Group, is a leader in the manufacture and distribution of in-vitro diagnostics and equipment essential for blood banks and transplant labs across Australia and beyond. We are dedicated to enhancing the quality and reliability of healthcare through innovation and excellence.

We are looking for a skilled Quality Assurance Senior Associate to join us at our GMP manufacturing facility. The Quality Assurance Senior Associate plays a pivotal role in supporting the quality of our operations and ensuring our customers receive safe, reliable, and best-in-class products.

Reporting to the Immulab Quality Assurance Manager, this role serves as a key voice for quality in our organisation — ensuring appropriate quality systems, controls, and improvements are effectively implemented throughout our GMP-licensed manufacturing facilities. You will work collaboratively with production, validation, and regulatory teams to ensure that all products are developed and released in accordance with applicable regulatory requirements, customer expectations, and industry standards.

Key Responsibilities

• Support the Quality Manager in implementing the Quality Assurance strategy across the organisation.
• Guide and mentor QA Associates in the execution of QA policies, systems, and procedures.
• Manage and review batch release activities in compliance with GMP and regulatory guidelines.
• Maintain and continuously improve the Quality Management System (QMS), including documentation control, deviations, change control, complaints, CAPA, training, and internal audits.
• Support quality investigations, validation programs, and risk management activities.
• Facilitate quality meetings such as Change Control panels and SQuIPP forums to ensure timely closure of quality events.
• Drive supplier quality and vendor management activities.
• Prepare for and support internal, customer, and regulatory audits to maintain a state of audit readiness.

About You

• A tertiary qualification in a scientific or quality-related discipline.
• 3+ years' experience in Quality Assurance within a GMP or IVD/medical device environment.
• Strong working knowledge of ISO 13485, ISO 9001, and TGA regulatory requirements.
• Excellent attention to detail, documentation, and communication skills.
• Proven ability to collaborate across teams, influence decision-making, and maintain composure under pressure.
• A proactive, solutions-focused mindset with a genuine passion for continuous improvement and product quality.

What's in it for You?

• Be part of a growing Australian sovereign manufacturer producing critical diagnostic products for blood safety.
• Work in a state-of-the-art, GMP-licensed facility with a supportive and collaborative team.
• Access professional development opportunities within the broader Paragon Care Group.
• Contribute to a mission that directly impacts healthcare outcomes in Australia and beyond.

About Us

Paragon Care, an ASX-listed leader in healthcare, specializes in supplying and servicing advanced medical equipment and consumables. We are committed to driving innovation and excellence in healthcare, shaping the future of diagnostics and decision-making.

Please note: Only successful candidates will be contacted.

Successful applicants will be required to complete a pre-employment medical, including a drug test and criminal history check, prior to starting. Open to Australian or New Zealand Permanent Residents or Citizens. Paragon Care values diversity and encourages applications from people with disabilities, Aboriginal and Torres Strait Islander people, and those from culturally diverse backgrounds.