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. Responsible for supporting the Scientific Operation team in the quality control of client reports, data analysis and data integrity inspections under the requirements of the company's NATA accreditation and other regulatory requirements. Responsibility AreasThe key responsibility areas (KRAs) are major outputs for which the position is responsible and not a comprehensive statement of all position activities.Safety Ensure the safe and efficient conduct of activitiesEnsure compliance to relevant internal processes and statutory requirementsTeamwork Maintain high levels of communication with colleagues and productive relationships with service providers and other partnersAccreditation Adhere to ISO/IEC 17025, OECD Principles of GLP, GCLP Principles, 360biolabs' Quality Management System, and other requirements as per NATA Accreditation and regulatory guidelinesQuality Control Ensure confidence in the reliability, quality and integrity of source data and source documentation for laboratory assaysQuality control client reports and conduct data integrity checksQuality control data transfers and conduct data integrity checks on source and analysed dataAssist in identifying deviations, CAPA and lab investigations associated with laboratory dataMaintain awareness of International Standards and guidelines for Quality SystemsProfessional Development Attend meetings associated with Quality Control or the work of 360biolabsParticipate in professional activities including training courses and seminarsReview SOPs, systems and procedures to assure the quality and integrity of service offerings at 360biolabsMaintain records to levels consistent with relevant standards and industry expectationsKey Selection CriteriaBachelor of Science (Hons) or equivalent qualification plus relevant experience (Essential)Experience / Knowledge / Attributes Experience in a quality-controlled laboratory environment (preferably ISO/IEC 17025) (Essential)Knowledge of laboratory techniques & 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 Word 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)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.
Benefits of working with 360biolabs include working with the best people (and technology) in our field, local and global career opportunities and a genuine focus on wellbeing and connection. In addition, competitive remuneration packages will be offered to successful applicants based on skills and experience.
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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