JT796 - SPECIALIST QUALITY COMPLAINTS

Quality Consulting Group • Juncos, PR

1d

About The Position

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

Requirements

• Bachelor's degree in related area
• Five (5) years of directly related experience to the job
• Experience in project management, root cause analysis, and Corrective and Preventive Action (CAPA) determination and implementation.
• Strong quality mindset with comprehensive knowledge of quality systems, cGMP compliance, and regulatory requirements.
• Proficiency in Microsoft Office Suite, including Excel and Outlook.
• Experience using Microsoft Teams for communication, collaboration, and cross-functional meetings.
• Strong analytical, organizational, and problem-solving skills with the ability to manage multiple priorities in a regulated environment.

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.
• Problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level