360biolabs is Australia's most comprehensive quality-accredited specialty laboratory services organisation. 360biolabs is a BioAgilytix company and part of a leading global contract research organisation (CRO) supporting the development of innovative new medicines in a quality-controlled environment. At 360biolabs, we develop and conduct pharmacokinetics (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas to ensure the success of our clients' clinical trials and preclinical studies.
Working at 360biolabs means working with the best people (and technology) in our field. With a genuine focus on development, you will have access to local and global opportunities. You will also have access to a diverse offering of wellbeing and connection initiatives which reflects that people are our priority.
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.
Quality Management
- 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
Safety
- Attend all required safety training and ensure compliance to relevant internal processes and statutory requirements
Team Work
- Maintain high levels of communication with colleagues and productive relationships with service providers and other partners.
Accreditation
- 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.
Professional Development
- Attend meetings associated with Quality Management or the work of 360biolabs
- Participate in professional activities including attendance at conferences, training courses and seminars
Data Analysis, Reporting and Document Work
- 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
Key Selection Criteria
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 (careers@360biolabs.com).
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.
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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.
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