Product 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 strong technical background in the pharmaceutical industry, coupled with excellent project management and communication skills. The position requires a proactive, detail-oriented individual with a commitment to quality and customer service.

Requirements

Bachelor’s degree in Quality or 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), and use of Teams.

Nice To Haves

Being self-motivated, curious, creative, with an eye for detail.
Commitment to serving customers with high-quality research and products.
Embracing a diverse work culture.
Interest in environmental considerations.

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.