CAPA Investigator Job at Robert Half, Round Lake, IL

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  • Robert Half
  • Round Lake, IL

Job Description

Job Description

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.

• 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.

Job Tags

Long term contract, Contract work, Local area, Shift work, Weekend work,

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