On-site Lead QC Scientist, Molecular Diagnostics

Genetic Signatures Ltd.; Australia; Hybrid; AUD 90,000 - 130,000; Full time

Job summary

Genetic Signatures Ltd. is seeking a Senior Quality Control Scientist to join the on-site Quality Control team in Newtown for a full-time role (38 hours per week).

You will perform QC testing of EasyScreen IVD products, conduct stability testing, and manage QC projects while supporting manufacturing and technology transfer. The role requires strong molecular biology and real-time PCR expertise, attention to detail, and leadership capabilities, with experience in ISO 13485 environments and CAPA

Qualifications

• Bachelor of Science with Molecular Biology or related discipline.
• Experience in molecular diagnostics, real-time PCR, and nucleic acid extraction.
• Experience in ISO 13485 regulated manufacturing environments.
• Exposure to CAPA, non-conformances and audits desirable.
• Strong documentation and quality control knowledge.

Responsibilities

• Perform QC testing of EasyScreen IVD products.
• Conduct stability testing and support shelf-life extensions.
• Review and approve QC data for batch release and stability studies.
• Manage QC projects and workflows.
• Support manufacturing, production and technology transfer activities.
• Maintain quality documentation including SOPs and work instructions.
• Support CAPA, deviation and audit activities.
• Provide leadership, mentoring and supervision of QC staff where applicable.

Skills

Molecular biology

Real-time PCR

Quality data analysis

Leadership

Education

Bachelor of Science in Molecular Biology or related discipline

Tools

Real-time PCR instruments

Job description

Genetic Signatures Ltd. is seeking a Senior Quality Control Scientist to join the on-site Quality Control team in Newtown for a full-time role (38 hours per week).

You will perform QC testing of EasyScreen IVD products, conduct stability testing, and manage QC projects while supporting manufacturing and technology transfer. The role requires strong molecular biology and real-time PCR expertise, attention to detail, and leadership capabilities, with experience in ISO 13485 environments and CAPA