Telecommute Clinical Trial Quality Assurance Auditor II

Job Summary

A clinical trial solutions company needs applicants for an opening for a Telecommute Clinical Trial Quality Assurance Auditor II.

Individual must be able to fulfill the following responsibilities:

• Manage all aspects of audits / audit conduct
• Plan, conduct, and report audits according to company’s standard operating procedures
• Track and/or trend audit issues and/or CAPAs until closure

Required Skills:

• Travel: 0-10%
• Bachelor’s degree or equivalent required, preferably in life sciences, trial or quality management
• 3+ years' relevant experience in areas of Quality Assurance, Auditing, Validation, and/or SDLC systems
• Strong working knowledge of Good Clinical Practices, ICH Guidelines, Software Validation requirements
• Knowledgeable of 21 CFR Part 11, Annex 11, and other applicable ERES regulations