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Company Name: Cardinal Health - CHI
Job Title: Manager, Quality Assurance
Location: Waekugan, IL
Profession: Quality Control/Assurance

Job Description:

At Cardinal Health, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.

Function: QRA
Family: Quality Assurance


What Quality Assurance contributes to Cardinal Health
Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective.


What is expected of you for success in your role


  • Demonstrates depth and breadth of knowledge of quality assurance systems and approaches

  • May lead teams or projects and shares expertise

  • Interprets regulations and standards

  • Develops compliance strategies while balancing appropriate risk

  • Applies quality system skill sets to improve quality assurance outcomes Addresses complex problems and non-standard solutions

  • Responsible for cost-effective quality assurance systems and strategies





Qualifications


 
What is expected of you and others at this level in Quality & Regulatory Affairs for functional success

  • Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces

  • Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results.

  • Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications.

  • Encourages informed Risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources.

  • Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity


Accountabilities in this role
      


  •  Leads QS driven business unit projects that promote standardization and lean processes.

  •  Focuses on identifying project deliverables, establishing and managing to timelines, managing through opportunities, keeping team on task, and documenting project status reports

  • Identifies regulatory risks with the PRMS system, submits systems requests to address identified risks, and represents Quality in IT prioritization meetings to ensure completion of required programming changes.

  • Manages the prioritization and execution of software systems validations to maintain the integrity of the Quality System and to ensure projects remain on schedule. Approves the Validation Plans and Final Reports for business unit system validations

  • Performs problem solving through the application of six sigma techniques

  • Evaluates the need for validation using risk assessment techniques when programming changes are to be implemented

  • Coordinates manufacturing protocols related process improvements for key QS initiatives

  • Provides technical support for Quality team

  •  ERP Quality System integration: oversight, design, security, maintenance, compliance and validation.

  • Oversees pedigree compliance for Presource




Qualifications


  • Bachelor's degree required

  • Advanced degree preferred

  • 6-8 years applied experience

  • Knowledge of FDA regulations, Quality Control and Documentation



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