Specialist Quality Complaints

Flexible & Integrated Technical Services, LLC•Juncos, PR

1d•Onsite

About The Position

This role is for Quality Complaints services within the Operations & Transformation area. The ideal candidate will have a Bachelor's degree in Industrial Engineering with four years of directly related experience in the Pharmaceutical industry. Fluency in English and strong Project Management skills are essential. The position operates on an administrative shift schedule, adaptable to business needs.

Requirements

Bachelor’s degree in Industrial Engineering
Four (4) years of directly related experience in the Pharmaceutical industry
Fluent in English
Project Management skills
Experience in Project Management, Root Cause Analysis, CAPAs determination
Quality mindset and deep compliance knowledge
Proficient in Microsoft Office programs (Excel, Outlook), usage of Teams, and proficient in Artificial Intelligence programs (ChatGPT)

Nice To Haves

Being self-motivated, curious, and anxious to explore all possibilities
Creative with an eye for detail
Commitment to serving customers with high-quality research and products
Embracing a diverse work culture
Environmental consciousness

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.
On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible for conducting and documenting the investigation.
Possess excellent writing skills that include closing the gap between a highly technical investigation and 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.