Quality Control Scientist
- Experience Level
- Experienced (non-manager)
- Molecular Diagnostics
Our client is an Australian Biotechnology success story transforming molecular diagnostics. Their proprietary molecular diagnostics platform technology provides hospitals and pathology laboratories the ability to screen for a wide array of diseases and infectious pathogens with a high degree of specificity and with rapid high throughput. Their continued long-term goal is to target health conditions where faster and more accurate diagnosis plays a pivotal role in improving community health both in Australia and across the globe. Now is an exciting time to be joining our client as they undergo further expansion.
Reporting to the QC manager, the QC Scientist will work within the Quality Control team to ensure the timely release of high quality IVDs to their exacting standards. The QC Scientist will be required to:
- Assist with all QC processes involved in the release of IVD Pathogen detection products
- Real-time PCR amplification and detection of microbial pathogens within human clinical specimens and QC material
- Perform testing of Sample Processing methods for isolation of various microbial nucleic acid from a variety of human clinical specimens.
- Analysis of QC test results for various Pathogen Detection Kits
- Thorough documentation and reporting of test results prior to kit release
- Design and conduct experiments to assess efficacy and stability of Sample Processing and Pathogen Detection Kits
- Assistance with manufacturing steps including formulation, dispense, labelling
- Be meticulous in documentation completion for all tasks
- Adhere to ISO 13485 and the Quality Management System - QMS
- Comply with appropriate safety, record keeping and quality requirements
- An MSc./PhD in Biomedical Science or a related field
- At least 2 years' experience in a manufacturing/QC department of a diagnostic, pharmaceutical or medical laboratory
- At least 2 years real-time PCR experience
- Experience in compliance with principles of ISO 13485
- Excellent time management and organisational skills
- Flexibility to move with changing priorities in this fast-paced environment.
- Experience in and understanding of the expectations of a commercial environment
- Familiarity with molecular diagnostics an advantage
- Outstanding problem solving and interpersonal skills
Our client offers an exceptionally dynamic and progressive work environment. This fulltime role is at the frontline of development of new innovative technologies. They expect, and provide, excellent professional standards and work ethics. As a valued member of this team, you will have the opportunity to demonstrate your talent and shape this new and exciting company.
Salary is 75-80K plus super dependent on experience.
To join our client in this exciting opportunity please email your cover letter & CV to firstname.lastname@example.org. Confidential enquiries to Marilyn Jones on 61 40 100 3553.
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