Job Posting: Root Cause Investigation Contractor

      Indianapolis, IN


      Position Overview


      Coordinate and document investigations following root cause analysis techniques for excursions from Exelead instructions, specifications, and expectations. Also complete corrective and preventative actions from investigations per agreed action plans. Guide the setup/revision of raw materials (MEF) as they are introduced to the GMP site.


      Major Position Activities & Responsibilities


      • Oversee the timely completion of assigned investigations
      • Utilize project management techniques to coordinate completion of investigation tasks by personnel from areas throughout Exelead
      • Following root cause analysis techniques compile investigation inputs into a technical document that describes the investigation and supports the root cause(s) identified.
      • Propose corrective and preventive actions that directly address root causes from investigations
      • Complete assigned corrective and preventive actions per agreed action plans and timing
      • Serve as primary creator/guide for the Material Evaluation Form (MEF) process.
      • Other quality related warehouse duties as assigned.




      • The primary responsibility of this position is to complete assigned investigations and CAPAs by the required due dates. Investigations assigned will be from multiple areas including Materials Management, Supply Chain, & Manufacturing.


      Background Qualifications


      • Bachelor’s degree or equivalent work experience in pharma or other FDA regulated industry
      • Experience in handling and writing of nonconformances, risk assessments, investigations
      • Experience in Materials Management and/or GMP warehouse practices
      • Demonstrated technical writing capability
      • Previous experience managing projects with inputs from multiple people and areas


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