Overview
At Australian Biotechnologies, we're proud to be Australia's leading manufacturer of allograft implants, honouring the gift of donation and improving the wellbeing of patients nationwide. Our products support a wide range of surgical procedures, helping clinicians deliver the best possible outcomes for patients.
Australian Biotechnologies is guided by a set of values; we demonstrate integrity by encouraging teamwork, we value relationships by showing respect and honouring customers and staff, we value performance by embracing safety, quality and innovation. These values define who we are and how we work. We encourage and support our employees to live these values every day, and we offer a range of benefits to help you thrive, including
* Weekly staff wellness program.
* Health Insurance and gym discounts.
* On-site parking.
* Career opportunities to grow and develop.
* Rewarding job where you can make a difference by enhancing the lives of others.
Role
As a Senior Quality Officer at Australian Biotechnologies you'll lead validation activities and project work owning the Validation Master Plan, reviewing protocols, and managing re‐qualifications. You'll drive batch review/release, advanced non‐conformance/CAPA/change control and audit response, while partnering with Engineering, Operations and Regulatory to ensure cGMP and Human Tissue GMP compliance and continuous improvement.
Your key responsibilities
* Support process validation and risk assessment activities to ensure regulatory compliance and process robustness
* Take ownership of complex quality system tasks, including management of non-conformances, CAPAs, and change controls
* Manage the schedule for internal audit and participation external audits, ensuring accurate documentation and timely closure of findings
* Assist in the implementation of new products and equipment, contributing to qualification and quality planning
* Batch review and release
* Conduct batch record reviews and perform product release in accordance with GMP requirements
* Support and mentor team members in quality-related activities; deliver GMP and competency-based training as needed
* Engage in quality improvement initiatives and cross-functional quality-related projects
* Prepare and report monthly quality metrics and system performance trends
Qualifications
* Tertiary qualification at a minimum of bachelor's level in a science-related discipline, with coursework in microbiology
* Strong verbal and written communication skills
* Exceptional attention to detail, with the ability to identify and address potential issues proactively
* Proven ability to work independently following initial guidance
* Effective time management and organisational abilities
* Advanced computer literacy, particularly with Microsoft Office applications
* Proactive, forward-thinking mindset with a strong team-oriented approach
* Preferably over 3-5 years of experience in a similar role within a TGA-regulated environment
We are part of EBOS MedTech, which operates in nine countries through its portfolio of companies; Australian Biotechnologies (allograft manufacturing), Cryomed Aesthetics (aesthetic technologies), LifeHealthcare (ANZ medical device distribution), and Transmedic (medical distribution across SE Asia and Hong Kong).
Across all these businesses, we are united by a shared value: Connect. It shapes how we build strong relationships, share knowledge, and work together to deliver better outcomes for our customers, our people, and the communities we serve.
This onsite role based at Frenchs Forest, presents a fantastic opportunity to be part of a high-performing team and make a meaningful difference every day.
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