Quality Assurance Associate

Quality Assurance Associate  

• Competitive remuneration package plus superannuation

• Social events 

• Career development opportunities 

• Full time Position  

About the company

This business is a leading TGA/GMP-licensed pharmaceutical company with a strong presence in both Australian and global markets. We manufacture and supply high-quality products and radiopharmaceuticals supporting Nuclear Medicine, Oncology, and specialised contract manufacturing services. We play a key role in advancing patient care and medical diagnostics.

Culture

You’ll join a collaborative and values-driven team based at the Belconnen office. The culture is open, respectful, and focused on continuous improvement, where ideas are welcomed and quality is everyone’s responsibility. Team members are supported to grow, speak up, and contribute meaningfully to how the business operates.

Your new role

Reporting to the Quality Assurance Manager, you will be part of the Radpharm Scientific Quality Department. In this role, you’ll help ensure products are manufactured and released to the highest quality and regulatory standards, supporting clinicians and patients who rely on these medicines every day.

What you will get in return

• A supportive, family-oriented work environment

• Opportunities for professional growth and career development

• Team building activities and social connection

• A birthday day off to celebrate you

Key Responsibilities

1. Prepare and review quality system documentation including SOPs, specifications, batch manufacturing records, and periodic product review reports

2. Collate and analyse quality system data to support effective trending and continuous improvement

3. Support and facilitate QMS processes including change control, deviations, system reviews, and quality meetings

4. Perform batch release as an Authorised Person

5. Support internal and external auditing programs

6. Maintain up-to-date knowledge of GMP standards and regulatory requirements

7. Maintain a working knowledge of Radpharm Scientific final products and contract manufactured products.

8. Keep personal training records current and compliant

9. Promote and support a culture of continuous improvement

10. Act as a delegate for the QA Manager when required

 What you will need to succeed

• Strong organisational skills and attention to detail

• The ability to communicate effectively with a wide range of stakeholders

• At least 2 years’ experience in a Quality role within the healthcare or pharmaceutical industry

• High proficiency in writing technical and procedural documentation

• A Bachelor’s degree in Science

• Experience in sterile manufacturing or testing environments

• Sound knowledge of TGA and GMP regulatory requirements