Responsible for supporting and maintaining the Quality Systems of 360biolabs under the requirements of the company’s NATA accreditation and other regulatory requirements. Key responsibilities include document control; internal audits; client report and data transfer inspections; deviations, nonconformities and CAPA investigation and reporting; support staff training and competency programmes, support the proficiency testing programme; support equipment maintenance programme; and other tasks related to the Quality System.
Key Responsibility Areas
- The key responsibility areas (KRAs) are major outputs for which the position is responsible and not a comprehensive statement of all position activities.
- Maintain awareness of International Standards and guidelines for Quality Systems
- Conduct document control, including preparation, review and issue of new and updated documents; coordination of document reviews
- Conduct internal audits
- Investigate and report deviations and nonconformities; prepare and coordinate Corrective and Preventive Actions
- Provide support to the Proficiency Testing Programme
- Provide support to the equipment management programme, including equipment qualification and equipment calibration/service report review
- Support staff training and competency programmes, including follow up of staff training records
- Attend all required safety training and ensure compliance to relevant internal processes and statutory requirements
- Maintain high levels of communication with colleagues and productive relationships with service providers and other partners.
- Adhere to ISO/IEC 17025, OECD Principles of GLP, GCLP Principles, 360biolabs’ Quality Management System, and other requirements as per NATA Accreditation and regulatory guidelines.
- Attend meetings associated with Quality Management or the work of 360biolabs
- Participate in professional activities including attendance at conferences, training courses and seminars
- Review policies, SOPs, systems and procedures to assure the quality and integrity of service offerings at 360biolabs
- Quality assure client protocols and reports and conduct data integrity checks on data transfers
- Maintain records (LIMS, database and paper) to levels consistent with relevant standards and industry expectations
Quality Management
Key Selection Criteria
- Bachelor of Science (Hons) or equivalent qualification, plus relevant experience (Essential)
- Two years' experience in Quality Assurance, working with Quality Management Systems (QMS), or equivalent relevant experience (Essential)
- Experience in a quality-controlled laboratory environment (preferably ISO/IEC 17025) (Essential)
- Knowledge of laboratory techniques and assays (Desirable)
- Excellent organisational and writing skills (Essential)
- Ability to work as part of a team (Essential)
- Good communication skills (Essential)
- Proficient in use of Microsoft Office, including Word, Excel, and PowerPoint (Essential)
- Experience with database software and file management (Essential)
- Experience in the conduct of early phase clinical trials (Desirable)
- High motivation and enthusiasm for medical research, therapeutic and vaccine development (Desirable)
Applications close on 23rd September 2026. Please submit your application via the job link if you're interested in joining us, as we’re not able to process applications sent by email. For further information, please contact our Careers Team ([email protected]).
Apply now if you have what it takes to join our team!
360biolabs is a flexible, equal opportunity employer looking for committed and like-minded people to join us. Our culture is something we are very proud of, celebrating each individual and everything they bring to our team. We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQIA+ community and people with a disability.
To learn more about how we collect, use, and protect your information, please review our Privacy Policy and Terms of Use.
To express your interest in this position please submit a CV and cover letter. Applications only accepted from Australian / NZ residents with valid Australian work rights.
#360biolabs
Skills Required
- Bachelor of Science with Honours or equivalent qualification
- Two years of experience in Quality Assurance, Quality Management Systems, or equivalent relevant experience
- Experience in a quality-controlled laboratory environment, preferably ISO/IEC 17025
- Excellent organisational and writing skills
- Ability to work as part of a team
- Good communication skills
- Proficiency with Microsoft Office, including Word, Excel, and PowerPoint
- Experience with database software and file management
- Knowledge of laboratory techniques and assays
- Experience conducting early-phase clinical trials
- Motivation and enthusiasm for medical research, therapeutic, and vaccine development
What We Do
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory. BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.
