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 recent 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.This role will be responsible for supporting the Scientific Operations team in the quality control of client reports and data transfers to ensure the quality and accuracy of the work performed and reported and to eliminate errors, and to perform this under the requirements of the company's Quality Management System.Responsibility AreasThe key responsibility areas (KRAs) are major outputs for which the position is responsible and not a comprehensive statement of all position activities.Quality ControlConduct systematic Quality Control reviews of client reports and data transfersDeliver findings, observations and comments to scientific teams and conduct follow-up reviewsLead the close out of QC reviewsHelp ensure that high quality,



accurate data are delivered to the clientAssist in identifying deviations, CAPA and lab investigations associated with laboratory data; and aid in addressing these where applicableRecord Keeping and Document WorkComplete records as per required by company SOPsMay be required to review company documents (E.g. SOP revisions) as per applicable to the roleAccreditationAdhere to the company's Quality Management System which includes all Standard Operating Procedures (SOPs), noting we operate under NATA accreditation (ISO/IEC *****, OECD Principles of GLP, and GCLP Principles) and are required to comply with ICH Good Clinical Practice for all clinical studiesComplete training and maintain awareness of applicable standards, regulations and guidelines as per applicable to the roleSafetyEnsure the safe and efficient conduct of activitiesEnsure compliance to company OHS processes and statutory requirementsTeamworkMaintain effective communication with colleagues,



service providers and other partners.Work as a team both with QC and scientific departments to achieve client-ready reports and data transfersProfessional DevelopmentAttend meetings associated with Quality Control or the work of 360biolabsParticipate in training courses and seminars as related to the roleKey Selection CriteriaQualificationsBachelor of Science (Hons) or equivalent qualification plus relevant experience (Essential)Experience / Knowledge / AttributesExperience in a quality-controlled laboratory environment (preferably ISO/IEC *****) (Essential)Knowledge of laboratory techniques & assays (Desirable)Excellent organisational and writing skills (Essential)Ability to work as part of a team (Essential)Valuable communication skills (Essential)High Attention to detail and a willingness to learn and ask questions (Essential)Proficient in use of Word Office, including Word, Excel, and PowerPoint (Essential)Experience with database software (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 10th November **** at 9:15AM.360biolabs is a adaptable, 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.Applications only accepted from Australian / NZ residents with valid Australian work rights.
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📌 Qc Analyst (Melbourne)
🏢 BioAgilytix
📍 Melbourne