Quality Assurance Associate

Quality Assurance Associate

Position Title:

Quality Assurance Associate

Department:
 Clinical Operations

Reports to:
Head of Clinical Projects

Employment Type:

[Part-time (0.2 FTE) / Contract]

Location:

Australia (Remote/Hybrid/On-site options available)

NOTE: MUST HAVE CRO EXPERIENCE SPECIFICALLY

About the Role

We are seeking a proactive and detail-oriented Quality Assurance Associate to support, resource, and advise the business across all aspects of clinical quality assurance. This position ensures that clinical research activities are conducted in compliance with Good Clinical Practice (GCP), applicable regulations, sponsor requirements, and organisational quality standards. The role plays a critical part in maintaining audit readiness, supporting the Quality Management System (QMS), and driving operational excellence within clinical operations.

Key Responsibilities

·      Support and maintain the organisation's clinical quality, compliance, and risk management frameworks to ensure adherence to GCP and applicable regulatory standards.

·      Manage, implement, and enhance the Quality Management System (QMS), ensuring that all clinical processes and documentation meet internal and external compliance expectations.

·      Maintain QMS components, including document control, training records, deviation and CAPA logs, and change control registers.

·      Lead and coordinate the preparation, review, and version control of Standard Operating Procedures (SOPs), Work Instructions (WIs), and quality-related documentation relevant to clinical research activities.

·      Assist in planning and conducting external and  internal audits and support sponsor and regulatory inspections, ensuring timely follow-up of findings and CAPA implementation.

·      Oversee document control processes, ensuring clinical study documents, quality records, and training files are complete, accurate, and compliant.

·      Support the identification, investigation, and resolution of deviations, non-conformances, and audit findings, contributing to effective root cause analyses and CAPA implementation.

·      Conduct risk assessments and gap analyses to identify process improvement opportunities across clinical operations and quality systems.

·     Work collaboratively with Clinical Operations, Data Management to ensure consistent application of quality standards and continuous compliance readiness

Qualifications and Experience

·      Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, or a related field.

·      Previous experience working within the clinical research or clinical trials industry is essential.

Key Competencies

·      Attention to detail and commitment to data accuracy.

·      Strong problem-solving and critical-thinking skills.

·      Demonstrated understanding of quality assurance principles, auditing processes, and GCP compliance within a clinical research or clinical trials environment.

·      Proven experience with Quality Management Systems (QMS), including setup, maintenance, and continuous improvement.

·      Ability to learn and adopt new systems and technologies quickly and effectively.

·      Excellent interpersonal, communication, and leadership skills, with the ability to collaborate across multidisciplinary clinical teams.

Why Join Avion?

·      Opportunity to contribute to cutting-edge research in oncology and radiopharmaceuticals.

·      Collaborative and innovative work environment.

·      Competitive compensation and benefits package.

·      We offer hybrid working arrangements and flexibility in working hours to ensure our staff achieve the work-life balance often missing in this role.