Quality Assurance Associate (Nedlands)

Quality Assurance Associate (Nedlands)

About Us

The Quality Assurance (QA) team here at Linear plays a crucial role in establishing and maintaining robust quality systems that ensure trials are designed, conducted, recorded, and reported according to Good Clinical Practice (GCP), ethical principles, and applicable regulations across our Cancer Trials and Early Phase units. By performing routine audits, providing guidance on standard operating procedures, and supporting continuous process improvement, the team helps to identify risks early and prevent deviations that could compromise data credibility or patient/participant welfare.

We now have an opportunity for a Quality Assurance Associate to join the team commencing in January.

Your Role in Our Future

In this role you will work with various teams to support trial delivery across both our cancer trials and healthy volunteer studies to deliver key quality activities including CAPA management, vendor qualification, provide regulatory advice and computerised system validation and host client audits and inspections.

Some of your duties will include;

- Provide support and advice to Business Unit agents in the management of quality incidents.

- Lead the qualification of new critical external vendors and maintain the Master Approved Vendor list.

- Ensure CAPA's are appropriately recorded, tracked and managed from issue identification to resolution.

- Carry out internal audits across Linear's processes, systems, studies and documents ensuring trials are conducted in accordance with applicable GCP regulations and contractual agreements.

- Review and update Standard Operating Procedures, Policies and supporting documents ensuring all staff are informed of QMS updates.

The Job Description will provide you with more information on the role which will be based in Nedlands and offered on a full-time basis for a period of 12-months in the first instance.

Your Experience

The ideal candidate for this role will come with previous experience within a comparable role, ideally from within a pharmaceutical,



research or medical organisation along with a supporting Tertiary qualification. You will be a strong team player and be able to work collaboratively to support business units whilst promoting the value and importance of quality assurance within our organisation.

You must also be able to demonstrate;

- Previous experience in Quality Assurance, auditing or managing quality systems.

- Robust attention to detail and commitment to quality.

- Excellent organisational skills with the ability to meet multiple and competing deadlines.

- Advanced communication skills including proven written, verbal, negotiation and presentation skills.

- Previous experience in delivering training to an audience.

Our Culture and Benefits

We encourage a workforce that is innovative, eager to acquire knowledge and enhance skills; we embrace all employee differences and foster a culture that supports diversity and inclusion. We value our people and offer a generous range of benefits to support you to maintain a healthy work/life balance. These include:

- Not-for-Profit salary packaging benefits reducing your taxable income by up to $18,550.

- 5 weeks annual leave.

- Access to discounted health insurance and gym membership.

- Social events.

- Training and development opportunities.

- Employee Assistance Program for you and your family.

How to Apply

If you think that this is the right role and an exciting new challenge for you, please click on 'Apply Now' to submit your application and cover letter (no more than 2 pages) which should specifically address your skills and experience outlined in the “Your Experience” section above.

Closing Date: 17th December. Please note, Linear reserves the right to hire prior to the closing date.

Linear encourages applications from people of all ages, nationalities, abilities, and cultures. This includes Aboriginal and Torres Strait Islander peoples, CALD (Culturally and Linguistically Diverse), the LGBTQI+ community, and people with disability. We value inclusivity and are committed to adjusting our recruitment process to ensure accessibility and support of an applicant's needs.

📌 Quality Assurance Associate (Nedlands)
🏢 Linear Clinical Research
📍 Nedlands