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Senior GLP Quality Auditor/Specialist

Employer
AbbVie
Location
North Chicago, IL, US
Start date
Jun 30, 2019

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

The Senior GLP (Good Laboratory Practice) Auditor/Specialist is primarily responsible for providing quality consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of work-related processes and new product development programs worldwide.

Responsibilities:

  • Carry out job duties independently, including study-specific inspections, internal system / process based-audits, and external supplier CRO (contract research organization) audits. Requires minimal supervision or direction.
  • Independently plan and conduct internal systems audits, external supplier CRO audits and due diligence assessments for merger/acquisition and in-licensing opportunities. Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues.
  • Gather internal audit metrics, perform trend analysis and present to management.
  • Provide guidance and training on GLP regulations and guidelines for auditors and functional area personnel.
  • Collaborate with and assist the Inspection Management group on preparation for and support of inspections by regulatory agencies.
  • Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities.
  • Elevate issues to management, as necessary, in meeting these responsibilities.
  • Lead goals with cross-functional or broader scope and resolve team issues with minimal oversight.
  • This is an experienced level quality assurance auditor position. This individual is expected to identify and resolve problems, have effective interpersonal skills, work independently, mentor QA auditors, and also be an effective cross-functional team lead.


  • Bachelor's degree, preferably in life sciences or engineering.
  • Must have demonstrated strong leadership competencies, broad technical capabilities, and independence.
  • 6+ years' experience in function or related fields, such as, toxicology, bioanalytical laboratory, analytical chemistry, clinical pathology, Quality Assurance and/or Regulatory Affairs.
  • In-depth knowledge of global GLP/GCP 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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