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.
Key Responsibilities
Complaint Review & Triage
- Review and triage incoming complaints daily (5–6 per day; ~20–30 per week)
- Determine appropriate handling approach:
- Full investigation vs. documentation review
- Monitor and document complaint intake and triage decisions
Investigation Management
- 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
- Risk assessments
- 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
Continuous Improvement
- Support process improvements and productivity initiatives within the complaints program
- Identify recurring issues and contribute to quality system enhancements
Basic Qualifications
- 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