# Quality Complaints Specialist - Product Investigations

**Company:** [BioPharma Consulting JAD Group](https://jobs.workable.com/companies/pScfjBzGATtPx3geL93jwD.md)
**Location:** Juncos, Puerto Rico
**Workplace:** on site
**Employment type:** Contract
**Department:** Amgen

[Apply for this job](https://jobs.workable.com/view/e246d63d-cf6e-4341-aa38-d34e1a888393)

## Description

Support the product complaint system at a leading biotechnology company in Juncos, Puerto Rico. You will lead and manage product complaint investigations and use data analysis and trending to detect signals early and drive timely action.

**What you'll do**

-   Keep the complaints database current and accurately summarize closed investigations.
-   Review and approve complaint investigations to make sure they are concise, clear and science-based.
-   Lead and document investigations directly when the nature or complexity of the complaint requires it.
-   Follow up on corrective actions from investigations through completion.
-   Trend complaint data to proactively detect signals and recommend actions.
-   Communicate and escalate complaints, represent the site on the product complaint network, and issue closure letters to patients and business partners.

## Requirements

-   Bachelor's degree + 4 years (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate) of directly related experience.
-   GMP quality experience with complaint or quality investigations, root cause analysis and CAPA determination.
-   Excellent technical writing: able to turn a highly technical investigation into a clear document for non-technical reviewers.
-   Project management and experience leading cross-functional teams across multiple projects.
-   Strong communication, facilitation and presentation skills; able to work independently in a matrix environment.
-   Proficient in Microsoft Office (Excel, Outlook) and Teams. Bilingual English/Spanish preferred.

## Benefits

-   Contract: 5 months, with possible extension
-   Shift: Administrative, Monday–Friday (40 hours/week)