QC Analyst

MelbourneHybrid

AI Summary

Performs systematic quality control reviews of client reports and data transfers for a laboratory supporting pharmacokinetic and pharmacodynamic assays, closing out findings and ensuring accurate data under NATA/ISO 17025 and GLP/GCLP requirements.

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.

This role will be responsible for supporting the Scientific Operations team in the quality control of client reports and data transfers to ensure the quality and accuracy of the work performed and reported and to eliminate errors, and to perform this under the requirements of the company’s Quality Management System.

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 Control

Conduct systematic Quality Control reviews of client reports and data transfers

Deliver findings, observations and comments to scientific teams and conduct follow-up reviews

Lead the close out of QC reviews

Help ensure that high quality, accurate data are delivered to the client

Assist in identifying deviations, CAPA and lab investigations associated with laboratory data; and aid in addressing these where applicable

Record Keeping and Document Work

Complete records as per required by company SOPs

May be required to review company documents (E.g. SOP revisions) as per applicable to the role

Accreditation

Adhere to the company’s Quality Management System which includes all Standard Operating Procedures (SOPs), noting we operate under NATA accreditation (ISO/IEC 17025, OECD Principles of GLP, and GCLP Principles) and are required to comply with ICH Good Clinical Practice for all clinical studies

Complete training and maintain awareness of applicable standards, regulations and guidelines as per applicable to the role

Safety

Ensure the safe and efficient conduct of activities

Ensure compliance to company OHS processes and statutory requirements

Teamwork

Maintain effective communication with colleagues, service providers and other partners.

Work as a team both with QC and scientific departments to achieve client-ready reports and data transfers

Professional Development

Attend meetings associated with Quality Control or the work of 360biolabs

Participate in training courses and seminars as related to the role

Key Selection Criteria

Qualifications

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

Experience / Knowledge / Attributes

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)

High Attention to detail and a willingness to learn and ask questions (Essential)

Proficient in use of Word Office, including Word, Excel, and PowerPoint (Essential)

Experience with database software (Essential)

Experience in the conduct of early phase clinical trials (Desirable)

High motivation and enthusiasm for medical research, therapeutic and vaccine development (Desirable)

Skills

CAPADatabase SoftwareEarly Phase Clinical TrialsExcelGCLPICH Good Clinical PracticeISO/IEC 17025Laboratory AssaysLaboratory InvestigationsMicrosoft WordNATA AccreditationOECD GLPPowerPointQuality Control ReviewStandard Operating Procedures