Quality Assurance Associate

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

• The key responsibility areas (KRAs) are major outputs for which the position is responsible and not a comprehensive statement of all position activities.

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

Qualifications

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

Experience / Knowledge / Attributes

• Two years' experience in Quality Assurance, working with Quality Management Systems (QMS), or equivalent relevant experience (Essential)

• Experience in a quality-controlled laboratory environment (preferably ISO/IEC 17025) (Essential)

• Knowledge of laboratory techniques and 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 Microsoft 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)