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Senior Quality Assurance Professional

3 weeks ago

City of Greater Geelong, Australia beBeeQuality Full time $86,500 - $144,000

Job Title: Quality Assurance Specialist

Job Description

We are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of the quality assurance group, you will be responsible for ensuring that all clinical research activities adhere to regulatory standards and company policies.

The successful candidate will have a deep understanding of regulatory frameworks and risk-based auditing methodologies. You will lead and execute comprehensive quality and compliance audits in accordance with regulations and standards governing clinical research.

You will develop and implement strategic, risk-based audit plans to proactively identify areas of concern and ensure regulatory compliance. Your expertise will guide both internal and external stakeholders on GxP requirements and quality assurance strategies.

Key Responsibilities:

  • Develop and implement strategic, risk-based audit plans
  • Lead and execute comprehensive quality and compliance audits
  • Provide expert consultation on GxP requirements and quality assurance strategies
  • Analyze and interpret audit findings to author or direct the preparation of detailed audit reports
Requirements

To be considered for this role, you must have:

  • A minimum of 7-9 years of experience in a quality auditing function within a contract research organization (CRO), pharmaceutical, biotechnology, or related organization
  • A strong understanding of research ethics and privacy
  • Previous experience leading a team is required

Certifications such as Certified Auditor (ASQ, ISO, or equivalent) are strongly preferred.

Benefits

This is a home-based, remote position with regular office-hours. The salary range is $86,500 - $144,000 per year plus bonus.