Address
Form of workWe have an opportunity for a dynamic Quality Control Manager to join an agile and creative medtech start-up, ZiP Diagnostics.
You will be part of a team creating innovative point-of-care tests against human and animal infectious diseases. You will be improving health and well-being globally. You will help to improve access to healthcare, especially in community-based settings and low-middle income countries. You will be part of a diverse team of skilled R&D scientists, production scientists, and engineers. You will be based at our new facilities in the inner-Melbourne suburb of Collingwood.
Effective Date: Immediate appointment
Your responsibilities will include:
- Oversee Quality Control activities and supervise QC staff.
- Support the Quality Management System and Manufacturing teams in performing their functions.
- Oversee the QC testing of key laboratory/production reagents and consumables (e.g. raw materials, subcomponents, final products).
- Conducting investigations of out of specification results and deviations to processes
- Oversee QC validation processes for laboratory and production activities.
- Oversee product analytical and clinical validation testing.
- Support development and optimisation of new tests and assays (when necessary).
- Support assessment of prototype instruments with chemical reagents and biological samples (when necessary).
- Support maintenance of laboratory research materials and processes including clinical samples, human ethics, ordering of reagents/ equipment, ensuring high quality safety practices for the lab and its members, ensuring compliance with all AQIS and other quality requirements.
- Conduct training sessions and assess task competencies for laboratory and production staff.
- Assist with the preparation of materials for reports, publications or presentations.
- Attendance and participation in meetings. Regular reporting to Quality Manager.
Essential Selection Criteria:
- Experience in Quality Assurance and Quality Control processes.
- Knowledge of biological systems including clinical and public health applications of diagnostic tests.
- Experience in the preparation of scientific and technical reports.
- Capacity to undertake wet lab validation testing.
- Practical lab skills in cell culture, molecular assays, working safely with human samples.
- Understanding of Good Clinical Laboratory, Manufacturing and Practice.
- Experience in keeping accurate laboratory records and inventories.
- To conduct all research in an ethical and professional manner. Adherence with all company defined regulations.
Desirable Selection Criteria:
- Experience working in the in vitro diagnostics industry
- Experience in cleanroom manufacturing
- Experience working with ISO or NATA Quality Management Systems
Remuneration: According to experience.
To apply:
Written applications addressing the selection criteria and a detailed resume should be emailed to Dr Jack Richards, ****@zipdiag.com by 31st January 2024
