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Senior GLP Quality Auditor

Employer
AbbVie
Location
North Chicago, IL, US
Start date
Jul 3, 2019

View more

Discipline
Administration, Accounting, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

The Senior GLP Quality Auditor is primarily responsible for carrying out tasks related to core job responsibilities by providing quality consultation, auditing and coordination of projects necessary to maintain and improve the quality of work-related processes.

Responsibilities :

  • 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.
  • 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.
  • Expected to participate on cross-functional project teams.


  • Bachelor's degree preferred; typically 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).

Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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