Summary

We are seeking a Complaints Investigator to support complaint investigations related to manufacturing operations within a regulated pharmaceutical environment. This role will focus on coordinating investigations, collecting and analyzing relevant data, evaluating potential process impact, documenting findings, and supporting the timely closure of complaints.

Responsib​ilities: 

• Investigate complaints related to manufacturing operations.
  
• Coordinate complaint investigations with appropriate cross-functional teams.
  
• Collect, review, and analyze data from available systems and data repositories.
  
• Support the evaluation of potential manufacturing process impact associated with complaints.
  
• Document investigation findings, conclusions, and supporting evidence.
  
• Support the timely and compliant closure of complaints.
  
• Maintain accurate and complete investigation documentation.
  
• Perform other duties as assigned.
  

Requirements

• Bachelor’s Degree completed.
  
• 2–4 years of relevant experience, including prior investigation and/or complaint experience in Parenteral or Solid Dosage manufacturing.
  
• Strong investigation, analytical, documentation, and problem-solving skills.
  
• COMET System experience is a plus.
  
• Willing and able to work 100% on-site in Gurabo, Puerto Rico.