QA Specialist

2 days ago

Australia beBeeQuality Full time $90,000 - $114,000
Quality Assurance Professional

As a Quality Assurance Associate, you will play a vital role in ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements. Your primary responsibility will be to support the development, implementation, and maintenance of our quality assurance program and related policies and procedures.

The ideal candidate will possess excellent communication skills, both written and verbal, and have the ability to work effectively within a team environment. You should have a strong attention to detail, be highly organized, and have excellent analytical skills.

Your responsibilities will include:

  • Conducting internal study audits to ensure compliance with applicable regulatory and organisational procedures.
  • Conducting internal process audits to verify compliance with internal processes and applicable regulatory requirements.
  • Assisting with vendor audits and audits conducted by sponsors.
  • Contributing as a member of the investigational team for CAPAs.
  • Maintaining an up-to-date knowledge of the latest requirements relating to GCP and regulatory requirements in Australia and overseas.

Key qualifications and skills:

  • Bachelor's degree in a life science field.
  • Minimum 2 years' experience as a Quality Assurance professional operating in a GCP or GxP environment with ICH-GCP training.
  • Formal audit training or evidence-based internal/study audit training.
  • Intermediate MS Office suite.

In return, we offer:

  • A fun, friendly work environment.
  • A culture that values honesty and respect.
  • A sense of belonging to a strong, supportive team.

To apply, please submit your CV and cover letter as one Microsoft Word document. Please note that full Australian working rights are required for this position.

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