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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.

CAPA Specialist - Corrective Action/Preventive Action

Chicago, Illinois Req ID 2201991 Category Quality Assurance Division AbbVie

Oversees the Business Technology Solutions (BTS) CAPA System by performing and approving root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for IT Systems.

  • Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements
  • Coordinates the exception document process and creates/approves exception documents
  • Independently leads complex, high impact investigations
  • Ensures all investigations are written according to corporate requirements
  • Ensures all applicable regulatory requirements are met for the implementation and maintenance of the Quality System
  • Ensures all Quality CAPA goals and metrics are met
  • Promotes culture of continuous improvement by identifying problems, conducting root cause analysis, and confirming appropriate implementation of corrections, corrective and preventive actions
  • Maintains an effective liaison and cooperative relationship with other BTS organizations.
Qualifications:
  • Bachelor's degree in a technical field, like Biology, Chemistry, Engineering, Computer Science, etc
  • 6+ years of experience in the pharmaceutical or medical device industries
  • Demonstrates ability to problem solve and utilize analytical skills
  • Knowledge of Quality/Compliance management, Regulations and Standards

 

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
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