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


Meet Some of Advanced Clinical's Employees

Lizzie E.

Market Development Manager

Lizzie collaborates with the Marketing, Business Development, and Operations Teams to develop and distribute educational and intriguing content that promotes brand awareness across Advanced Clinical’s functions.

Domantas G.

Associate Director, Clinical Monitoring

As Associate Director of Clinical Monitoring, Domantas is responsible for leading the Monitoring Team’s efforts to ensure the highest quality across clinical trials conducted at Advanced Clinical.


Back to top