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Accountabilities:

  • Initiate and execute internal, site and vendor audits and assessments to assess quality standards.
  • Provide QA advice on complex procedures to Clinical staff.
  • Perform quality review of QMS documents.

Requirements:

  • Bachelor's degree in a science, technology, or related field.
  • Extensive knowledge of legislation, regulations, clinical processes, industry practices and ICH-GCP guidelines.
  • 7+ years' experience in a relevant function in clinical research or a minimum of 5 years' experience in QA.

Benefits:

  • Medical, Dental, Vision, Life, Disability coverage.
  • 20 days PTO + PTO rollover + 13 paid holidays.
  • 401(k).

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