Job Description
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 cutting-edge 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.
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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.
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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.
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Key Responsibility Areas
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The key responsibility areas (KRAs) are major outputs for which the position is responsible and not a comprehensive statement of all position activities.
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Quality Management
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Maintain awareness of International Standards and guidelines for Quality Systems
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Conduct document control, including preparation, review and issue of new and updated documents; coordination of document reviews
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Conduct internal audits
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Investigate and report deviations and nonconformities; prepare and coordinate Corrective and Preventive Actions
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Provide support to the Proficiency Testing Programme
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Provide support to the equipment management programme, including equipment qualification and equipment calibration/service report review
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Support staff training and competency programmes, including follow up of staff training records
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Safety
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Attend all required safety training and ensure compliance to relevant internal processes and statutory requirements
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Team Work
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Maintain high levels of communication with colleagues and productive relationships with service providers and other partners.
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Accreditation
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Adhere to ISO/IEC *****, OECD Principles of GLP, GCLP Principles, 360biolabs' Quality Management System, and other requirements as per NATA Accreditation and regulatory guidelines.
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Professional Development
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Attend meetings associated with Quality Management or the work of 360biolabs
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Participate in professional activities including attendance at conferences, training courses and seminars
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Data Analysis, Reporting and Document Work
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Review policies, SOPs, systems and procedures to assure the quality and integrity of service offerings at 360biolabs
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Quality assure client protocols and reports and conduct data integrity checks on data transfers
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Maintain records (LIMS, database and paper) to levels consistent with relevant standards and industry expectations
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Key Selection Criteria
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Qualifications
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Bachelor of Science (Hons) or equivalent qualification, plus relevant experience (Essential)
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Experience / Knowledge / Attributes
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Two years' experience in Quality Assurance, working with Quality Management Systems (QMS), or equivalent relevant experience (Essential)
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Experience in a quality-controlled laboratory environment (preferably ISO/IEC *****) (Essential)
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Knowledge of laboratory techniques and assays (Desirable)
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Excellent organisational and writing skills (Essential)
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Ability to work as part of a team (Essential)
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📌 Quality Assurance Associate (Victoria)
🏢 BioAgilytix Labs
📍 Victoria