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QC Analyst chez Bioagilytix

Bioagilytix · Melbourne, Australie · Hybrid

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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 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.

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 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 Control
  • Conduct systematic Quality Control reviews of client reports and data transfers
  • Deliver findings, observations and comments to scientific teams and conduct follow-up reviews
  • Lead the close out of QC reviews
  • Help ensure that high quality, accurate data are delivered to the client
  • Assist in identifying deviations, CAPA and lab investigations associated with laboratory data; and aid in addressing these where applicable
    • Record Keeping and Document Work
  • Complete records as per required by company SOPs 
  • May be required to review company documents (E.g. SOP revisions) as per applicable to the role
    • Accreditation
  • Adhere to the company’s Quality Management System which includes all Standard Operating Procedures (SOPs), noting we operate under NATA accreditation (ISO/IEC 17025, OECD Principles of GLP, and GCLP Principles) and are required to comply with ICH Good Clinical Practice for all clinical studies
  • Complete training and maintain awareness of applicable standards, regulations and guidelines as per applicable to the role
    • Safety
  • Ensure the safe and efficient conduct of activities
  • Ensure compliance to company OHS processes and statutory requirements 
    • Teamwork
  • Maintain 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 transfers
    • Professional Development
  • Attend meetings associated with Quality Control or the work of 360biolabs
  • Participate in training courses and seminars as related to the role

    • Key Selection Criteria

    Qualifications 
  • Bachelor 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)
  • 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)

    • Additional Information

    Applications close on 10th November 2026 at 9:15AM.  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.

     

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