JT405 - SPECIALIST QUALITY COMPLAINTS at Quality Consulting Group

Juncos, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Aug, 26

Salary

0.0

Posted On

30 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Product Complaint Investigation, Data Analysis, Root Cause Analysis, CAPA Determination, Project Management, Technical Writing, Compliance Knowledge, Microsoft Office, Artificial Intelligence, ChatGPT, Quality Mindset, Signal Detection

Industry

Outsourcing and Offshoring Consulting

Description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA Responsibilities: Supporting the product complaint system; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. 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. Possess 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. Qualifications: Bachelor in engineering (Industrial engineering preferred) Master's in science related is a plus 4+ years of related experience in regulated environment Experience in project management, Root cause analysis, CAPAs determination. Quality mind set and deep compliance knowledge. Proficient in Microsoft Office Program (Excel, outlook), usage of Team and proficient in Artificial intelligence programs (ChatGPT) Complaints Owner Administrative shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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Responsibilities

Manage and lead product complaint investigations, performing data analysis and trending to proactively detect signals. Ensure all investigations are science-based, concise, and result in completed corrective actions.