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.

We now seek a Quality Control Scientist, for 9-month parental leave cover, 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
• 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 IVDD).
• Methodical production technique and record keeping, in line with GMP
• Attention to detail
• Ability to work independently

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 [email protected]. 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.