1+ months

IT CAPA - Quality

Waukegan, IL

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

This position focuses on CAPA element of the Quality Management System. Duties and Responsibilities include, but are not limited to, the following:

  • Ensures CAPA system is fully implemented and integrated with other elements of quality management system. Promotes recognition of quality program among IT and business colleagues and collaborators.
  • Evaluates and provides guidance on the methods and procedures to input quality events into the CAPA system. Assists with analysis of quality data to identify problems or unfavorable trends that may require corrective or preventive actions.
  • Provides independent review of investigations associated with non-conformances and CAPA, deviations, and change control activities.  Challenges the quality data information system. Ensures that the data received by the CAPA system are complete, accurate and timely.
  • Oversees and monitors the open nonconformance’s to ensure all activities are being completed in a timely manner. Identifies recurring events and ensures appropriate actions are taken as necessary and any trends are escalated for review.
  • Leading/facilitating continuous improvement initiatives based on feedback, process monitoring results, etc. Provide guidance on the CAPA system, event descriptions, investigations, root cause analysis, and resolution plans.
  • Updates and reviews standard operating procedures, work instructions, forms and templates in support the CAPA Program.
  • Assists as needed in audits and inspections. Supports GxP inspections and audits from both internal and external regulatory authorities and collaborators and supports drafting of follow-up responses for all aspects of the business. 
  • Assists on special projects and performs other activities associated with tracking of CAPAs, deviations and other exception records.
    Job Family: Information Risk & Quality Assurance
    Division: ADD Diagnostics
    Travel: Yes, 10 % of the Time
    Medical Surveillance: No
    Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


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IT CAPA - Quality

Waukegan, IL

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Waukegan, IL

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