Quality Complaints Investigator & CAPA Lead

ECHO Consulting Group Inc; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

ECHO Consulting Group Inc. is seeking an experienced Product Complaint Investigator to support Amgen’s product complaint system.

The role involves leading investigations, data analysis, and proactive trending to detect signals and initiate timely actions. The position requires strong writing skills to translate complex technical investigations into clear reports, effective collaboration across functions, and CAPA follow-through.

Qualifications

• Doctorate or Master’s degree required with related experience.
• Bachelor’s degree with 4+ years related experience accepted as alternative.
• Associates with 8+ years or high school with 10+ years of related experience.
• Experience in quality/compliance and CAPA preferred.

Responsibilities

• Support product complaint investigations and database management.
• Lead and manage investigations and perform data analysis.
• Review and approve investigations to ensure science-based conclusions.
• Follow up on corrective actions and closure letters to patients/business partners.
• Communicate and escalate complaints as needed.
• Represent site on product complaint network.

Skills

Project management

Cross-functional leadership

Verbal & written comms

Team collaboration

Leadership

Problem solving

Analytical skills

Customer service

Decision making

GMP compliance

Education

Doctorate or Master’s with 2+ yrs related exp

Bachelor’s + 4 yrs related exp

Associates + 8 yrs related exp

High school/GED + 10 yrs related exp

Tools

Microsoft Office

Excel

Teams

Job description

ECHO Consulting Group Inc. is seeking an experienced Product Complaint Investigator to support Amgen’s product complaint system.

The role involves leading investigations, data analysis, and proactive trending to detect signals and initiate timely actions. The position requires strong writing skills to translate complex technical investigations into clear reports, effective collaboration across functions, and CAPA follow-through.