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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.

Quality GMP Compliance Auditor

Lake County, Illinois Req ID 2119211 Category Quality Assurance Division AbbVie

GMP Compliance Supplier Auditing role with the Americas Audit Team. A member of the global GMP Compliance and Auditing team this role focuses on suppliers within the Americas Region (North, South and Central America) that provide products, materials, components and services to the Pharmaceutical and Medical Device businesses within AbbVie. Global audits supporting both internal and external supplier teams are possible within the program.

Acting individually or as part of an audit team the successful candidate is responsible for executing on-site and virtual GMP audits of suppliers and third-party manufacturers to assure compliance to applicable global regulations and guidance. The auditor must assess technical and quality systems compliance to applicable regulations, provide clear and factual feedback in the form of a detailed report including observations and assess corrective/preventive actions proposed to remediate observed gaps.

The role requires the successful candidate to be self-managed, proactive, technically capable, and professional while representing the company in an external facing role.

Qualifications:

Education:

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.

Technical Knowledge

  • Must have a technical background and understand the GMP audit process.
  • Knowledge of global requirements related to Pharmaceutical and Medical Device GMP regulations for quality systems and compliance (FDA, EU, ISO, ICH etc.).
  • 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.

Personal Skills

  • 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
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 50 % of the Time
Job Type: Experienced
Schedule: Full-time
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