Complaint Investigator

Quality Assurance Complaint Investigator Position Overview

The Quality Assurance (QA) Complaints Investigator is responsible for conducting end-to-end complaint investigations for manufacturing and packaging issues related to prefilled devices, drug/device combination products, and parenteral products. This role focuses on evaluating incoming complaints, coordinating cross-functional investigations, and synthesizing findings into clear, compliant investigation reports in a regulated environment.

This position plays a critical role in ensuring product quality, regulatory compliance, and continuous improvement by identifying trends, supporting root cause analysis, and providing actionable recommendations.

Complaint Review & Triage

• Review and triage incoming complaints daily (5–6 per day; ~20–30 per week)
• Full investigation vs. documentation review
• Monitor and document complaint intake and triage decisions
• Conduct thorough complaint investigations (~75% require full investigation)
• Review product and batch history, including prior complaints and related deviations
• Collaborate with subject matter experts (SMEs) to support:
  • Batch record reviews
  • Technical evaluations
  • Initiate and support RCIs, trend investigations, and technical tasks as needed

Data Analysis & Reporting

• Compile investigation findings into formal, compliant reports
• Develop clear conclusion statements and recommend next steps (e.g., root cause analysis, CAPAs)
• Perform quarterly trend analysis on product and process performance
• Prepare and deliver monthly, quarterly, and ad hoc metrics and reports
• Present complaint data to site leadership and cross-functional teams

Cross-Functional Collaboration

• Partner with SMEs, quality, manufacturing, and engineering teams to support investigations
• Provide customer service and investigation support to internal and external stakeholders
• Maintain accountability for all assigned investigations and deliverables
• Support process improvements and productivity initiatives within the complaints program
• Identify recurring issues and contribute to quality system enhancements

• Bachelor’s degree in Biology, Life Sciences, or a related field
• Minimum of 3 years of experience in a regulated industry (pharma, biotech, or medical device)
• Experience with complaint investigations and quality systems
• Knowledge of regulatory requirements (cGMP, 21 CFR Part 820, ISO 13485)
• Strong analytical, problem-solving, and organizational skills
• Excellent written and verbal communication skills
• Proficiency with Microsoft Office; experience with Veeva or other QMS systems preferred
• Basic understanding of statistics and data analysis