QC Scientist

Genetic Signatures are 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. We…

Genetic Signatures are 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.

We now seek a Quality Control Scientist, for 6-month contract, to perform quality control testing required for manufacturing and release of EasyScreen IVD products, stability testing of products as required to support shelf-life allocations and extensions and assist with manufacturing activities including stock management, reagent manufacture, stability and contamination control of products.

As the successful candidate you will:

• Perform quality control testing required for manufacturing and release of EasyScreen IVD products as per GSL internal procedures and specifications
• Perform stability testing of products as required to support shelf-life allocations and extensions.
• Implementation of the production work plan according to agreed timelines
• Perform production and quality control of EasyScreen diagnostic kits when required
• Record and action any observed non-conformances or stock discrepancies
• Liaise with Production and R&D groups as appropriate
• Review and update production documentation including BWIs and SOPs
• Follow manufacturing instructions meticulously and record all work efforts where required
• Maintenance of appropriate safety, record keeping and quality requirements
• Assist the Production team to effectively transfer products from development to manufacturing
• Assist manufacturing activities including stock management, reagent manufacture, stability and contamination control of products
• Ensure compliance with Quality and Regulatory requirements
• Liaise with Production, Quality and Regulatory Affairs teams to ensure all manufacturing activities comply with QMS and regulatory requirements (including FDA, HC, TGA and IVD).
• Assist with CAPA investigations as required.

Essential for success as a QC Scientist are:

• A minimum of BSc. in Biomedical Science or a related field
• Understanding of nucleic acid extraction, real-time PCR and molecular diagnostic fields
• Knowledge of regulatory status and requirements of products (i.e. TGA, HC, FDA and IVDR).
• Methodical production technique and record keeping, in line with GMP
• Ability to work independently and be proactive

It is advantageous if your personal talent tool kit includes:

• Experience in an ISO 13485 accredited manufacturing environment, specifically in QC activities
• Experience in a commercial environment

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 apply with a cover letter and CV via email at careers@geneticsignatures.com. All applications will be treated in the strictest confidence. Please note that due to the expected large number of applications, only those who are short-listed will be contacted for an initial interview.

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.