1+ months
2018-05-232018-08-19

Sr. Specialist IT - CAPA

Abbott
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.

Primary Function

  • Leads the IT Compliance activities for specific CAPA (Corrective and Preventive Action) event evaluations, investigations and resolution planning.  Typically has responsibility for medium to large events.
  • Assembles CAPA SME team with all needed parties/expertise to effectively and efficiently address assigned CAPA events.
  • Ensures CAPA events are investigated and remediated according to schedule.
  • Applies IT project delivery, application support and compliance knowledge and experience to CAPA investigations. 
  • Prepares and approves documentation per policy and procedure to support CAPA activities. 
  • Provides understanding and leadership of CAPA processes, SLC, validation and compliance processes/procedures.
  • Accountable for capturing, reporting and evolving the CAPA metric data for BTS.  Prepares management review metrics for upper management communications and provides input as needed for GMR metrics
  • Monitors implementation plan and effectiveness check due dates and works with BTS IT owners to ensure implementations are completed on time.
  • Escalates ER status, implementation and effectiveness issues to CAPA management as needed.
  • Works with Event owners to ensure CAPA Dashboard reflects the current status of all IT CAPAs

    Core Job Responsibilities

    • Develops the CAPA strategy and approach for medium to large CAPA events. 
    • Assembles and leads virtual team to develop, review and approve CAPA documentation (evaluation, investigation, containment, resolution, implementation, and effectiveness checks) in support of IT quality activities
    • Understands the IT operating model and is adept at forming a team of SMEs to complete all aspects of the CAPA within the needed timelines.  Holds team members accountable.  Escalates appropriately.  Creates ownership and momentum across needed organizations, functions and partners.
    • Communicates CAPA progress by producing status reports to provide timely and accurate status to IT management.
    • Performs work using standard methodologies, processes and tools to ensure IT Compliance.
    • Resolve issues that may delay the CAPAs or otherwise subject the company to financial or regulatory risk.
    • Establishes CAPA tasks and timelines and is held accountable to them.
    • Capture and report on IT Compliance data and metrics for assigned CAPAs and identifies potential process improvements

      Compliance/Regulations

      Adheres to established policies and procedures and assists in the establishment of regulated policies and procedures at the departmental level.

      Relationship Management

      Establishes and maintains productive relationships with all levels in the BTS and Divisional IT organizations and business functions. Acts as a liaison and IT Compliance expert to assure successful investigations and corrective actions.  Serves as a source of information on the IT Compliance needs and regulatory environment.

      Accountability/Scope

      Works with minimal management direction.  Drives completion of CAPAs by organizing and monitoring the efforts of CAPA SME teams.   

      Decision Making

      Independently conceives and develops approaches to the solution of CAPA events which require application of IT compliance principles.

      Complexity: Medium-High

      Business Impact

      Errors or failure to achieve expected results may result in quality issues and/or the expenditure of more resources or impact IT compliance.

      Education

      Bachelor’s Degree or equivalent certification or experience.  No advanced degree required

      Experience/Skills

      • 4-6 years of experience in a IT project delivery, IT application support, SLC methodologies, CAPA and quality systems environment.
      • Either is a CAPA certified event owner or will work to achieve this certification
      • Excellent analytical, judgment, consultative capabilities and communication skills.  The ability to work with both IT management and staff.
      • Builds needed relationships and drives for results.
      • Excellent written communication skills.
        Job Family: Information Risk & Quality Assurance
        Division: GIS Global Information Services
        Travel: No
        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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Sr. Specialist IT - CAPA

Abbott
Waukegan, IL

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