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Form of workABOUT THE COMPANY
We are a biotechnology company committed to providing innovative health products to improve the quality of life for our patients. Operating under the Therapeutics Goods Administration regulatory framework for biologicals, this is an excellent opportunity to work in a regulated environment with a great team culture.
ABOUT THE ROLE
You will be a part of the quality team based in our manufacturing facility in Frenchs Forest, NSW.
Your key responsibilities will include:
- Receipt of incoming tissue, and where applicable, associated testing specimens.
- Quality control testing of tissue, collection and dispatch of samples from all incoming tissue in compliance with documented protocol.
- Assume responsibility for complex tasks related to quality systems, including advanced handling of non-conformances, Corrective and Preventive Actions (CAPA), change controls, internal/external audits, and documentation. Ensure the timely and efficient completion of tasks.
- Participate in monitoring of clean room pod environment and storage equipment. Respond to monitoring alarms to contain and protect products.
- Assist Daily QC tasks (In - process monitoring plates analysis, inspection and clearance of returned grafts)
- Perform batch review and release.
- Assist other staff in performing quality-related tasks. Provide GMP and competency training for staff where required.
- Participate in Quality-related projects.
- Preparation of monthly quality metrics and system trending for reporting.
- Assist and conduct other quality tasks as required.
ABOUT YOU
- Tertiary qualification with minimum bachelor-level education in a science-based discipline that includes studies in microbiology.
- Excellent verbal and written communication skills.
- Very high level of attention to detail. The ability to identify and act on potential issues.
- Demonstrated ability to work independently, after initial instruction.
- Efficient time management and organisational skills.
- Excellent computer skills - in particular experience using MS Office programs
- Be forward thinking, proactive and have a team-orientated attitude.
- 2-3 years’ experience in a similar role in TGA regulated environment, preferred.
JOB BENEFITS AND PERKS
- Weekly staff wellness program.
- On-site parking is available.
- Opportunities to grow and develop.
- Rewarding job where you can make a difference by enhancing the lives of others.
Immediate start is available due to staff promotion.
If you are interested in applying for this position, please submit your resume and cover letter via the ''Apply for this job"" button below.
Please note that only shortlisted candidates will be contacted for an interview.
Strictly no agencies, please.
