Genetic Signatures is a global molecular diagnostics company, driving improved patient outcomes using our innovative 3base™ technology to provide configurable clinically relevant molecular diagnostic solutions for infectious diseases.  We support leading pathology laboratories around the world and with a keen focus on meeting our customer needs, we continue to expand our global customer base.

To help support our growing company, we now seek a permanent full time Validation Scientist to perform the studies required for domestic and international regulatory submissions.

As the successful candidate you will:

• Perform analytical studies for new nucleic acid extraction kits and real-time PCR assays
• Assist with some aspects of process, equipment and computer software validation
• Analyse data and assist with problem solving and experimental design
• Prepare study protocols and reports
• Be meticulous in keeping documentation for all tasks, as required by our Quality Management System
• Ensure compliance with project management principles

Essential for success as a Validation Scientist are:

• A minimum of BSc. in Biomedical Science or a related field
• Previous experience in an assay development or validation role for medical devices or other regulated products
• Previous experience with product or process or equipment validation
• Molecular biology experience including Real-time PCR
• Strong problem solving and analytical skills
• A flexible and adaptable attitude
• Excellent time management and organisational skills

It is advantageous if your personal talent tool kit includes:

• Experience in assay validation in compliance with TGA/FDA or EU regulations
• Computer software validation experience
• Ability to independently source technical information, formulate hypotheses, design experiments and interpret the results
• Experience in compliance with principles of ISO 13485
• Familiarity with the regulated environment and experienced in undertaking controlled studies to support regulatory submissions

The successful applicant will be rewarded with a competitive remuneration package, commensurate with experience.

If this sounds like your next career opportunity and you want to make a difference to healthcare outcomes, apply now, we can’t wait to hear from you!

Please send your application to [email protected]. All applications will be treated in the strictest confidence.

 

Genetic Signatures Ltd is committed to providing equal employment opportunities, we thrive on the diversity of thought present in our workforce and encourage anyone possessing the talent and drive to better health care for their community to apply. All qualified applicants will receive consideration for employment without regard to race, colour, religion, national origin, gender, age, sexual orientation, gender identity, disability, status as a Veteran or other protected classification