- Experience Level
- Experienced (non-manager)
- 0.6 FTE Part time or Full time
- New role due to growth
Our client Crux Biolabs is the go-to biomedical experts for quality, custom services to facilitate pre-clinical and clinical research and development in Australia. Their expert scientists have years of experience tailoring custom biomarker detection and cell assays for many satisfied academic, biotech, pre-clinical and clinical studies.
Reporting to the Chief Operating Officer, your key remit will be to ensure that all processes, procedures, documents, and records are completed to ensure compliance with ISO 17025 and quality requirements within the Quality Management System (QMS). You will have broad systems oversight and perform inspections of the laboratory records, ensuring that Standard Operating Procedures (SOPs) were complied with, review reports, and ensure customer requirements are met. You will be independent from laboratory operations and may be responsible for interacting with customers or suppliers on Quality and/or performance issues.
- Provide Quality oversight for the company.
- Quality representative for the company, particularly with external regulatory bodies.
- Report Quality metrics and management reviews to management.
- Support an environment that promotes compliant operations.
- Oversee day-to-day quality compliance of the company.
The Position Requirements
- Bachelor's degree in biological/life sciences or related area. Higher degree preferred. Additional experience may be substituted for degree.
- Minimum 4 years of experience in a Quality Assurance role, preferred as Quality Manager.
- ISO/GMP regulated environment expertise.
- Regulated industry with Quality Assurance (QA) background.
- Experience in the maintenance of the QMS, including auditing, non- conformances, change control, vendor assurance etc.
- Experience in the requirements of regulatory bodies, e.g., NATA, TGA, FDA.
- Excellent analytical, technical, and problem-solving skills.
- Strong organizational and time management skills.
This role is available as a part time 0.6 FTE Quality Manager role. Alternatively, if you bring expertise in administration, Human Resources, or financial management, then a full-time role will also be considered.
To join our client in this exciting opportunity please email your cover letter & CV to email@example.com. Confidential enquiries to Marilyn Jones on 1300 0 MEXEC.
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