Quality Auditor I

Overview

With direction and oversight from the Head of Compliance and Quality, the Quality Auditor I provides support (which may include planning/conduct/follow-up) for internal audits/assessments, vendor assessments/audits, hosting client audits and supporting other quality department activities (inspection support, SOP writing/editing, etc.). The Quality Auditor I may also provide assistance to other auditors.

Responsibilities

  • Provides support (which may include planning/conduct/follow-up) for client audit activities
  • Provides support (which may include planning/conduct/follow-up) for internal audits/assessment activities
  • Provides support (which may include planning/conduct/follow-up) for vendor assessment/audit activities
  • Updates the applicable quality department tracking tools and repositories as required
  • Provides support for other quality department activities, including inspection support, SOP writing/editing, etc.
  • Provides support to other quality department staff, to include various co-auditing activities, as directed by management
  • Acquires knowledge of applicable regulations, including Good Clinical Practices and other relevant US and international regulations

Qualifications

  • Bachelor’s or equivalent degree in a relevant field of study (Quality, Business, Regulatory Affairs, Health Care, Research, etc.) is preferred
  • Applicable quality assurance, regulatory, or clinical research-related training is preferred
  • Has or will obtain within one year of hire at least one relevant certification (CQA, RQAP, RAC, etc.)
  • At least two years of experience in quality assurance, clinical research, regulated industry experience, and/or equivalent is preferred
  • Candidate must demonstrate proficient writing skills, be a good communicator, have good organizational skills, and be proficient with applicable software systems
  • Travel up to 10% may be required


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