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Job Description

Location: Goodfield IL

Logistics Engineer

Responsibilities will include:

• Conducting root cause analysis for each assigned CAPA.

• Gathering and analyzing data to support investigation findings.

• Collaborating with cross-functional teams to develop appropriate corrective and preventive actions.

• Drafting and finalizing investigation reports with clear justifications under each CAPA.

• Alignment of CAPA documentation with FDA 483 resolution needs.

• Participate in internal meetings, provide status updates, and address any gaps during the investigation process.

• Supporting responses to FDA inquiries as it pertains to CAPA status, as needed.

 

REQUIREMENTS:

5-7+ years of experience performing CAPAs