Quality Complaints Investigator & CAPA Lead

Cis-International-LLC; Juncos (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Amgen seeks a skilled professional to support the product complaint system, lead investigations, and analyze data to detect signals, enabling timely corrective actions. The role emphasizes high-quality, science-based investigations and clear, concise documentation for non-technical reviewers.

The candidate should excel in writing, project management, and cross-functional collaboration within a GMP environment to ensure compliance and patient safety in a fast-paced setting.

Qualifications

• Doctorate or Master’s with 2+ years related experience.
• Bachelor’s degree with 4+ years related experience.
• Associate’s degree with 8+ years related experience.
• High school/GED with 10+ years related experience.

Responsibilities

• Maintain and update the complaints database as information becomes available and summarize closed investigations.
• Review and approve investigations to ensure they are concise, clear, and science-based.

Skills

Project management

Written & verbal comms

GMP CAPA knowledge

Teamwork in matrix

Problem solving

Leadership

Microsoft Office

Education

Doctorate/Master's + 2y exp

Bachelor + 4y exp

Associates + 8y exp

High school/GED + 10y exp

Tools

Microsoft Office (Excel/Outlook)

Job description

Amgen seeks a skilled professional to support the product complaint system, lead investigations, and analyze data to detect signals, enabling timely corrective actions. The role emphasizes high-quality, science-based investigations and clear, concise documentation for non-technical reviewers.

The candidate should excel in writing, project management, and cross-functional collaboration within a GMP environment to ensure compliance and patient safety in a fast-paced setting.