Senior Auditor, GCP QA

Lake County, IL, US
Apr 18, 2019
Required Education
Bachelors Degree
Position Type
Full time
Primarily responsible for conducting audits of investigative clinical sites in R&D to assess and assure compliance with regulations, guidelines, policies, procedures and sponsor requirements

  • Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures.
  • Lead investigation site audits to ensure compliance to global regulatory requirements as well as AbbVie requirements. Effectively communicate audit results, both orally and in writing. Review corrective action plans/audit responses for adequacy and approve if adequate
  • Lead Global System Audits to evaluate internal Abbvie areas for compliance to applicable SOPs and local regulations
  • Review clinical research documents, such as research reports, to assess the quality and compliance to policies, procedures, and applicable governmental regulations
  • Assist in periodic audits to evaluate vendor R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable governmental regulations globally
  • Evaluate the potential risk of compliance deficiencies
  • Review policies and procedures and suggest improvements
  • Maintain effective communication of project related information
  • Provide training and consulting services to the organization to ensure GCP compliance
  • Assist with Clinical QA program management activities in support of studies and projects to ensure compliance with regulations, guidelines, policies, procedures and sponsor requirements

  • Bachelor's degree in a physical science, life science, nursing, pharmacy or equivalent experience required
  • 5-7 years of pharmaceutical industry experience in Quality Assurance I Regulatory Affairs
  • 5-7 years of clinical research and development
  • Minimum 2 years of QA auditing experience (GCP Auditing preferred)
  • Minimum of 7 years total combined experience required (not necessarily the sum of the above)