Quality Assurance Associate

Lever, Inc.; City of Melbourne; Hybrid; AUD 65,000 - 90,000; Full time

Job summary

360biolabs, Australia’s premier quality-accredited specialty laboratory, seeks a Quality Assurance professional to support the QMS and regulatory compliance within a clinical testing environment. You will contribute to document control, audits, CAPA investigations and proficiency testing, ensuring data integrity and adherence to ISO/IEC 17025 and NATA standards.

The role emphasizes teamwork, strong writing, and meticulous record-keeping, with opportunities to advance within a global CRO

Qualifications

• Bachelor of Science (Hons) or equivalent qualification.
• Two years' experience in Quality Assurance with Quality Management Systems (QMS).
• Experience in a quality-controlled laboratory environment (ISO/IEC 17025 preferred).
• Excellent organisational and writing skills.
• Ability to work as part of a team.

Responsibilities

• 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 CAPA actions.
• Provide support to proficiency testing and equipment management programmes; training and competency support.
• Maintain records (LIMS, database and paper) to standards and integrity of service offerings.

Skills

Quality Assurance

QMS

Lab techniques

Teamwork

Writing skills

Documentation

Education

Bachelor of Science (Hons) or equivalent qualification

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

• 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)