Quality Complaints Investigator & RCA Analyst

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

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,