Quality Complaints Investigator & CAPA

Inteldot

Puerto Rico

On-site

USD 65,000 - 90,000

Full time

3 days ago

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Job summary

Inteldot in Puerto Rico seeks an Administrative Shift to support Amgen's product complaint system, leading investigations, analyzing data, and trending information to detect signals and drive timely actions.

The role emphasizes concise, science-based investigations, writing skills to translate technical detail into clear reports, and collaboration across teams to ensure closure with patients and partners.

Qualifications

Experience in project management, root cause analysis, CAPA determination.
Quality mindset and deep compliance knowledge.
Proficient in Microsoft Office Programs (Excel, Outlook) and usage of Teams.

Responsibilities

Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
Follow-up on corrective actions derived from investigations through completion.
Responsible of conducting and documenting the investigation.
Excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.