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.

• Bachelor's degree in science, engineering, or a related field. • Minimum of 2-4 years of experience in a cGMP-related industry or clinical setting. • Strong problem-solving and analytical skills with an understanding of statistics. • Familiarity with TrackWise Management System is preferred. • Knowledge of US and International Regulatory requirements. • Ability to prioritize tasks and make independent decisions with minimal supervision. • Excellent communication, organizational, and facilitation skills. • Availability to work during off-shifts or weekends when needed.

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Round Lake, IL
onsite
Temporary
40.00 - 45.00 USD / Hourly
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.
2025-10-21T20:38:48Z

Capa Investigator Job in Round Lake | Robert Half