JT796 - SPECIALIST QUALITY COMPLAINTS

Quality Consulting Group • Juncos, PR

3d

About The Position

Quality Consulting Group is seeking a Specialist Quality Complaints to support the product complaint system in a pharmaceutical, biotech, medical device, or manufacturing environment. The role involves leading and managing product complaint investigations, analyzing and trending complaint data to identify potential signals, and taking timely appropriate action. The specialist maintains the complaints database, reviews and approves investigations, follows corrective actions through completion, and communicates complaint outcomes to patients and business partners. The position works in a matrix-managed GMP environment and represents the site on the product complaint network.

Requirements

• Bachelor's degree in a related area.
• Five years of directly related experience.
• Experience in project management, root cause analysis, and CAPA determination and implementation.
• 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.
• Excellent writing skills.

Responsibilities

• Support the product complaint system and lead and manage product complaint investigations.
• Analyze and trend complaint information to proactively detect signals and take appropriate action in a timely manner.
• Update the complaints database as factual information becomes available and accurately summarize closed investigations in the database.
• Review and approve complaint-related investigations to ensure they are concise, clear, and science-based.
• Follow up on corrective actions resulting from investigations through completion.
• Translate technical investigation findings into simple, concise documents understandable to non-technical reviewers.
• Communicate and escalate complaints, represent the site on the product complaint network, and generate and issue closure letters to patients and business partners.
• Apply problem-solving, analytical, influencing, and customer service skills to deliver results in a matrix-managed GMP environment.

What This Job Offers

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