Senior Auditor, GCP QA

Employer
AbbVie
Location
Lake County, IL, US
Posted
Apr 18, 2019
Ref
1902011
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
Responsibilities:

  • 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)