Bioagilytix29d ago

Quality Assurance Associate (18-month contract)

MelbourneFTmid

OtherQA & TestingQuality Assurance AssociateQuality Assurance Lead

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Overview

Technical Tools

exceldata-analysis

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.

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

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