Senior Clinical Trials Quality Assurance Specialist

7 days ago

Sydney, New South Wales, Australia On Q Recruitment Full time
About the Role

We are seeking a highly skilled Senior Clinical Trials Quality Assurance Associate to join our team at On Q Recruitment. As a key member of our clinical research centre, you will play a crucial role in upholding the operational compliance and quality management of early phase oncology clinical trial studies.

Key Responsibilities
  • Operational Compliance: Contribute to the overall operational compliance, including the oversight and maintenance of our Quality Management Systems (QMS), document preparation, and coordination of audits and inspections.
  • Quality Management: Analyze and manage corrective and preventative actions (CAPA), address complex site queries, and lead by example in fostering a culture of quality compliance and continuous improvement.
  • Regulatory Compliance: Support the development of a structured internal training program to strengthen regulatory and GCP compliance awareness across the clinical trial centre.
  • Team Collaboration: Work closely with our Clinical Trials Quality Assurance Manager and collaborate with cross-functional stakeholders to maintain positive relationships and adapt to a changing environment.
Requirements
  • 3 years of experience in a clinical trial quality assurance role in a pharmaceutical, biotechnology, and/or CRO environment, with investigational site experience preferred.
  • High level of quality and compliance mindset, with sound knowledge of GCP and other compliance audits and inspections.
  • Sound experience with CAPA management, conducting root cause analysis, and developing and implementing internal learning programs.
  • Adaptable and flexible, with strong problem-handling skills and the ability to showcase proactiveness in managing complex issues.
What We Offer
  • A competitive salary package with salary sacrifice up to $16k per year, allowing you to expense a portion of your salary on expenses to increase take-home pay.
  • A dynamic and collaborative team environment, with opportunities for professional growth and development.

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