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Bioagilytix

Posted 10 days ago

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Sample Reception Manager

MelbourneOn-site

AI Summary

Manages sample reception operations for a clinical laboratory, coordinating domestic and international sample logistics, LIMS tracking, and a team of reception staff while ensuring compliance with ISO/IEC 17025, GLP, and NATA accreditation standards.

About this role

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.

Coordinate and lead sample reception operations for a busy and modern laboratory as part of an integrated service adhering to best industry practice, regulatory guidelines, and SOP requirements.

Key Responsibility Areas

  • The key responsibility areas (KRAs) are the major outputs for which the position is responsible and are not a comprehensive statement of the position activities.
    • Laboratory Duties
  • Maintain the laboratories in an efficient and well-organised manner
  • Manage clinical sample registers and/or relevant records in the Laboratory Information Management System (LIMS)
    • Sample Reception
  • Ensure all aspects of domestic and international sample shipments and storage are conducted to a high standard liaising with Principal Investigators, Project Managers, Clinical Sites and clients as required.
  • Coordinate and optimise the tracking of clinical samples in the Laboratory Information Management System (LIMS) ensuring training and correct use by scientists and support staff.
  • Ensure equipment and systems are sufficient to track and monitor the storage of critical reagents and clinical samples across all storage environments including temperature-controlled environments for the duration of studies and as part of biobanking services.
  • As required: support Sample Logistics Officers by conducting sample receipt, retrieval or dispatch for internal testing and external shipments
  • Assess and recommend shipping methods, routing or carriers to meet necessary parameters, specifications and costs
    • Data Analysis, Reporting and Document Work
  • Conduct sample reception metric analysis and provide clear interpretation of data to others
  • Prepare, maintain and review policies, SOPs, systems and procedures to assure the quality and integrity of service offerings at 360biolabs
  • Maintain records (LIMS, database and paper) to levels consistent with relevant standards and industry expectations
  • Maintain records and produce reports to levels consistent with NATA accreditation, regulatory guidelines and industry expectations and communicate with clients and external bodies
    • Leadership
  • Provide leadership to drive the work ethic and culture of the sample reception team with a client and customer focus.
  • Proactively manage strategic relationships between internal resources and external entities such as vendors, service providers and partner organizations.
  • Managerial oversight of multiple Sample Reception team members, including managing priorities, supervision, training and staff development, performance reviews, 1:1s and providing regular feedback
  • Participate in defining milestones (Company, Group and Project) and ensure activities are aligned to deliver goals
    • 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
    • Safety
  • Ensure the safe and efficient conduct of laboratory activities
  • Ensure compliance to relevant internal processes and statutory requirements
    • Team Work
  • Coordinate responsibilities and provide oversight for the day to day priorities and operations of the Sample Reception Team.
  • Collaborate well in a cross functional matrix environment; maintain high levels of communication with colleagues and productive relationships with service providers and other partners.
    • Professional Development
  • Attend meetings and training associated with biological and clinical research and the work of 360biolabs where appropriate.
  • Participate in professional activities including attendance at conferences, training courses, and seminars

    • Key Selection Criteria

    Qualifications
  • BSc in a scientific discipline (Essential)
    • Experience / Knowledge / Attributes
  • Extensive experience in laboratory environment such as an analytical, pharmaceutical or pathology lab conducting sample testing (Essential)
  • Experience in the conduct of laboratory assays at a Contract Research Laboratory (Essential)
  • Experience working in a quality-controlled environment preferably an accredited facility following ISO/IEC 17025, GLP or similar quality-controlled environment (Essential)
  • Extensive people management experience (Essential)
  • Excellent organisational and time-management skills (Essential)
  • Ability to work as part of a team (Essential)
  • Excellent analytical, interpersonal, verbal and written communication skills (Essential)
  • Experience in handling clinical samples and international shipping and logistics (Desirable)
  • Experience with database computer software and file management (Desirable)
  • Experience with use and/or configuration of a Lab Information Management System (LIMS) (Desirable)
  • High motivation and enthusiasm for biomedical research (Desirable)

    • Skills

    Clinical Sample HandlingDatabase SoftwareGLPInternational Shipping LogisticsISO/IEC 17025Laboratory Information ManagementLIMSNATA AccreditationPharmacodynamic AssaysPharmacokinetics AssaysSample TrackingSOPsTemperature-controlled Storage

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