AbbVie

Senior GLP Auditor

Employer
AbbVie
Location
Lake County, Illinois
Posted
Jun 10, 2021
Ref
2107948
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

  • Primarily responsible for carrying out tasks related to core job responsibilities by providing quality consultation, auditing and coordination of projects to maintain and improve the quality of work-related processes.
  • Carryout job duties, by planning, organizing, and leading study-specific inspections and/or internal system/process-based audits. Requires some supervisory oversight.
  • Review raw data, protocols and research reports to assure the quality and integrity of the results as well as compliance to protocols, policies, procedures, and applicable governmental regulations; and be able to evaluate the potential risk of compliance deficiencies.
  • Provide guidance and training on GLP regulations and guidelines to Associate GLP auditors and functional area personnel.
  • Assist the Inspection Management group on inspections by regulatory agencies.
  • Prepare and present project progress reports to update management and keep the team(s) informed.
  • Participate on cross-functional project teams
  • This is an independent quality assurance auditor position. The individual is expected to demonstrate decision-making ability. However, this is a skills-mastering position with supervisory review and oversight.

Qualifications
  • Bachelor’s degree, preferably in life sciences or engineering.
  • 4+ years’ experience in function or related fields, such as, toxicology, bioanalytical laboratory, analytical chemistry, clinical pathology, Quality Assurance and/or Regulatory Affairs.
  • General understanding of GxP regulatory standards.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. 
  • Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ) Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA).

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.