Validation Scientist

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.

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 acidextraction kits and real-time PCR assays
• Assist with some aspects of process, equipment and computer software validation
• Analyse dataand 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 orprocess 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

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

If this sounds like your next career opportunity and you want to make a difference to healthcare in communities around the world, apply now, we can't wait to hear from you

Submit your application online, along with your CV

Submit your application online, along with your CV

We are always on the lookout for amazing and diverse talent to join the GSL team. We may not have the perfect opportunity for you right now, but possibly in the future. If you want to be part of our mission to make a difference in healthcare through transforming molecular diagnostics, register your interest by clicking below and we will send you aligned roles as they become available.

GSL is committed to providing Equal Employment Opportunity, all applicants with the right talent, qualification and drive 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.