QA and Compliance Auditor

Employer
AbbVie
Location
Lake County, Illinois, USA
Posted
May 23, 2018
Ref
1803782
Required Education
Bachelors Degree
Position Type
Full time
The function of Audit and Compliance Auditor I is to perform evaluations for compliance with US
and foreign regulation requirements (minimally may include the Americas, Asia, Africa, Australia,
European Middle East regions) and provide constructive evaluation of quality related systems for
suppliers that provide materials, services and products to AbbVie. Suppliers can include API
suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers.
Their execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness and safety of our products.

Key Responsibilities Includes :

  • Assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments of our suppliers, assuring compliance to regulatory requirements and AbbVie specifications.
  • Provide feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained at the supplier.
  • The position serves a tactical purpose for AbbVie and must achieve a difficult balance of
    involvement and objectivity.
  • Participate in strategic initiatives to improve compliance to regulatory requirements and standards.
  • Bachelor's Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology,Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries.
  • Must have a technical background and requires understanding of the audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.
  • Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.
  • The individual must have excellent oral/written communications skills.
    Personal skills needed include interpersonal skills, tact, open mindedness, maturity, tenacity, self reliance, organizational/administrative skills and sound judgment. Effective communication skills are essential with an ability to work effectively outside of the company and across functional and technical areas.
  • 2+ years in Quality Assurance with some project management experience in the pharmaceutical,medical device/nutritional or related industry. One year in compliance/auditing or regulatory affairs is desirable. Total combined experience expected to be at least 6 years.
  • ASQ certification desired, not required.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Travel:

  • 75%