Quality Complaints Specialist

Insight Global; Concord (NC); On-site; USD 75,000 - 105,000; Full time

Job summary

Insight Global is seeking a QA Complaint Investigator to conduct end-to-end investigations for manufacturing and packaging issues related to prefilled devices, drug/device combination products, and parenteral products. The role focuses on evaluating complaints, coordinating cross-functional investigations, and producing compliant reports in a regulated environment.

The position supports root cause analysis, trend identification, CAPAs, and continuous improvement by collaborating with quality,

Qualifications

• Bachelor’s degree required in Engineering, Life Sciences, or related field.
• Minimum 3 years in regulated pharma/biotech/medical device.
• Experience with complaint investigations and quality systems.
• Knowledge of regulatory requirements (cGMP, 21 CFR Part 820, ISO 13485).
• Strong analytic, problem-solving, and communication skills.

Responsibilities

• Review and triage complaints daily, prioritize investigations.
• Conduct end-to-end investigations and document findings.
• Collaborate with SMEs for batch records and technical evaluations.
• Develop formal investigation reports with clear conclusions.
• Perform quarterly trend analysis and report metrics.

Skills

Analytical thinking

Problem solving

Organizational skills

Written and verbal communication

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Tools

Microsoft Office

Veeva

Job description

The Quality Assurance (QA) Complaint 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)
• 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

Basic Qualifications

• Bachelor’s degree in Engineering, 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