Job Description
We are looking for a skilled CAPA Investigator Owner to join our team in Round Lake, Illinois, on a long-term contract basis. In this role, you will be responsible for managing non-conformance investigations, driving corrective actions, and ensuring compliance with regulatory standards. The ideal candidate will bring expertise in quality management systems, problem-solving, and regulatory requirements.
Responsibilities:
• Conduct thorough non-conformance investigations using the TrackWise Management System.
• Implement corrective and preventive actions (CAPAs) based on investigation findings.
• Maintain expertise in regulatory compliance and act as a resource for ensuring adherence to local and international regulations.
• Provide training and guidance to less experienced team members on problem-solving methodologies and process improvements.
• Ensure audit readiness for assigned areas, supporting compliance across the facility.
• Collaborate with cross-functional teams to prioritize tasks and uphold standard operating procedures.
• Utilize risk management tools to assess and mitigate potential issues.
• Support investigations and training outside of regular hours when necessary.
• Apply statistical analysis to facilitate data-driven decision-making.
• Drive continuous improvement initiatives using Six Sigma or Lean Manufacturing principles.
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