The Opportunity

An exciting opportunity is available for a Senior Quality Assurance Specialist to join the Burnet Diagnostic Initiative team at Burnet!

In this role you will assist research laboratories to perform industry-ready research and to develop easily transferable in-vitro diagnostic assays and therapeutic products to meet practical health needs. This exciting and interesting role is focused on implementing, maintaining, monitoring, improving and auditing the BDI ISO 9001 certified, or equivalent, quality management system (QMS). You will also assist laboratory staff in the design and development and provision of the BDI products and services, preparation of documentation for laboratory procedures, reagents, and equipment as well as the identification and assessment of Health and Safety risks associated with the work described in the documentation.

You will also:

• coordinate and perform document control activities.
• plan and conduct internal quality audits and prepare internal audit checklists and reports.
• assist with the Management Review process including slide pack preparation and taking minutes.
• develop and implement (incl. training of laboratory staff) laboratory QA processes and procedures with and across teams.
• design, perform, coordinate and/or monitor activities for laboratory equipment maintenance, verification, validation, calibration, servicing, and repair.
• assist with the quality control of laboratory products and services.
• perform clinical trial/study quality assurance activities as required (e.g. monitoring and quality control).
• provide verbal and written reports to management in meetings and via project/task management software when required.
• respond to and manage temperature-controlled equipment alarms outside work hours as required.
• travel to attend relevant work specific events (e.g. seminars, meetings or courses) to keep abreast of developments in the areas of work.
• travel for external and clinical study site audits may be required.

Refer to the attached position description for full details. This is a Full Time, Ongoing position. You will have flexible working hours as well as 2 days per week work from home option.

Let's talk about you

The following criteria are essential requirements:

• Bachelor of Science/Biomedical Science degree in a biological or clinical laboratory discipline.
• Several years of experience in a quality assurance role.
• Experience in working within an ISO 9001 certified environment or other standard/regulations (e.g. ISO 17025, ISO 13485, ISO 15189, GMP).
• Experience with internal quality auditing.
• Knowledge of techniques and tools for process improvement.
• Strong laboratory and technical skills.
• Experience with immunoassays, protein production and chemistry, molecular biology, clinical and/or translational research.

The following are preferable but not essential:

• Proficiency in the use of electronic laboratory notebooks (ELNs).
• Awareness of laboratory OHS and risk management issues in a range of settings.

The Burnet experience

We want you to have a successful and meaningful career at Burnet and are committed to providing a supportive workplace environment for all our people. You will be part of a collaborative culture where progressive leadership, innovation, respect, and excellence are valued. Join a team of talented individuals who are passionate about what they do - achieving a more equitable world through better health.

We offer:

• A monthly accrued day off for full-time staff
• 14 weeks paid parental leave - no qualifying period
• Additional long service leave - 17.3 weeks (minimum is 8.67) at 10 years of service
• Study leave
• Flexible working arrangements
• Generous salary packaging
• Opportunities for career and professional development

Who are we?

Burnet Institute is a leading Australian, unaligned, not-for-profit, organisation passionate about social justice, equality and evidence-based research.

Burnet Institute brings together a highly diverse skill base, with more than 400 staff and students working across cutting-edge research and projects to address some of the most relevant global health issues. Institute-wide interdisciplinary health programs Disease Elimination, Health Security and Pandemic Preparedness, and Women's, Children's and Adolescents' Health are at the heart of our daily decision making. Harnessing our international and local field presence, our laboratories, and our mixed development and research cultures drives a greater focus on the most relevant health issues and achieves a greater impact as a result.

Whilst our headquarters is in Melbourne, Australia, we also have offices in Papua New Guinea and Myanmar, and are actively involved in research and public health programs throughout Australia, the Asia-Pacific region and Africa. Burnet is the only unaligned organisation in Australia that has dual accreditation with both the Australian National Health and Medical Research Council (NHMRC) and the Department of Foreign Affairs and Trade (DFAT).

Bring your whole self to work

At Burnet, we foster a diverse and inclusive culture. We want our people to feel like they belong and are free to be themselves at work. We have an active Gender Equity, Diversity & Inclusion (GEDI) Council that works to promote and improve gender equity, diversity and inclusion across the Institute, by developing and implementing strategies informed by both national and international best practice and staff input. Burnet holds an Athena SWAN Institutional Bronze Award from Science in Gender Equity (SAGE). If you have a reasonable adjustment, support, or access requirement at any stage of the recruitment process, we encourage you to let us know by emailing [email protected] using the subject line: Senior Quality Assurance Specialist enquiry via EthicalJobs.

Sounds great! How do I apply?

Apply below and attach the following documents:

• Resume
• Cover Letter

As part of our commitment to gender equity, we have included a question in the application process on gender. This will allow us to monitor and report on gender in relation to our recruitment process.

Burnet is a child safe organisation. The successful applicant will be required to apply for a National Police Check and/or Working with Children. Current Australian working rights are required for all applicants.