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 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.

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.

Key Responsibility Areas

Quality Management

• Maintain awareness of International Standards and guidelines for Quality Systems
• Conduct document control, including preparation, review and issue of new and updated documents; coordination of document reviews
• Conduct internal audits
• Investigate and report deviations and nonconformities; prepare and coordinate Corrective and Preventive Actions
• Provide support to the Proficiency Testing Programme
• Provide support to the equipment management programme, including equipment qualification and equipment calibration/service report review
• Support staff training and competency programmes, including follow up of staff training records

Safety

• Attend all required safety training and ensure compliance to relevant internal processes and statutory requirements

Team Work

• Maintain high levels of communication with colleagues and productive relationships with service providers and other partners.

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.

Professional Development

• Attend meetings associated with Quality Management or the work of 360biolabs
• Participate in professional activities including attendance at conferences, training courses and seminars

Data analysis, Reporting and Document work

• Review policies, SOPs, systems and procedures to assure the quality and integrity of service offerings at 360biolabs
• Quality assure client protocols and reports and conduct data integrity checks on data transfers
• Maintain records (LIMS, database and paper) to levels consistent with relevant standards and industry expectations

Key Selection Criteria

Bachelor of Science (Hons) or equivalent qualification plus relevant experience

Essential

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.

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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