Senior Quality Complaints Investigator & CAPA Lead

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented professional to join our team in Puerto Rico and the USA to manage product complaint investigations within a GMP-regulated environment. You will analyze data, update the database, and drive corrective actions to closure, while communicating outcomes to patients and partners.

The role requires a strong quality mindset, experience with CAPA and root-cause analysis, and proficiency with Microsoft Office and Teams to collaborate across the

Qualifications

• Bachelor's degree in related area.
• Five (5) years of directly related experience to the job.
• Experience in project management, root cause analysis, and 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.
• Administrative Shift.

Responsibilities

• Lead and manage product complaint investigations with data analysis and trending.
• Keep the complaints database updated and summarize closed investigations.
• Ensure investigations are concise and science-based by review/approval.
• Follow up on corrective actions through completion.
• Write clear closure letters to patients and partners and escalate as needed.
• Represent site on the product complaint network and communicate with stakeholders.

Skills

Project management

Root cause analysis

CAPA

Quality mindset

Analytical

Problem-solving

Cross-functional collaboration

Education

Bachelor's degree in related area

Tools

Microsoft Office

Microsoft Teams

Job description

Quality Consulting Group, LLC is seeking a talented professional to join our team in Puerto Rico and the USA to manage product complaint investigations within a GMP-regulated environment. You will analyze data, update the database, and drive corrective actions to closure, while communicating outcomes to patients and partners.

The role requires a strong quality mindset, experience with CAPA and root-cause analysis, and proficiency with Microsoft Office and Teams to collaborate across the