Senior QC Scientist (On site, full-time -38 hours per week)

Genetic Signatures Ltd.; Australia; On-site; 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

Senior QC Scientist (On site, full-time-38 hours per week)

Newtown

We seek an experienced and motivated Senior Quality Control Scientist to join our Quality Control team. Key responsibilies will be quantlity control testing, stability testing, managing quality projects, supporting manufacturing and production, and providing leadership to the QC team.

Genetic Signaturesimprovespatient care and outcomes by developing innovative diagnostic technologies that simplify molecular pathology.

We are an Australian-based manufacturer supplying leading pathology laboratories locally and globally, and we are continuing to grow our collaborative, innovative and high-performing team.

We are currently seeking an experienced and motivated Senior Quality Control Scientist to join our Quality Control team on a full-time basis (38 hoursper week).

In this role you willbe responsible for:

• Performing quality control testing of EasyScreen™IVD products
• Conducting stability testing and supporting shelf-life extensions
• Reviewing and approving QC data for batch release and stability studies
• Managing QC projects and workflows
• Supporting manufacturing,productionand technology transfer activities
• Maintaining quality documentation including SOPs and work instructions
• Supporting CAPA, deviation and audit activities
• Providing leadership,mentoringand supervision of QC staff where applicable

To be successful as our Senior Quality Control Scientist, you willpossess:

• Strong molecular biology and real-time PCR knowledge
• Excellent attention to detail and documentation skills
• Strong communicationand leadership capabilities
• Ability to work independently and collaboratively
• Quality focused mindset and continuous improvement approach

Qualifications & Experience:

• Bachelor of Science with Molecular Biology or related discipline
• Experience in molecular diagnostics, real-timePCRand nucleic acid extraction
• Experience in PC1 and PC2 laboratories
• Experience in ISO 13485 regulated manufacturing environments
• Exposure to CAPA, non-conformances and audits highly desirable

At Genetic Signatures, every patient is important. Our molecular diagnostic solutions empower healthcare professionals to make informed decisions, improve patientoutcomesand build trust in every treatment journey.

If you have any questions about this role, please contact our team at [e-mail].

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