Quality Complaints Investigator & CAPA Lead

Mirus Consulting Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico, seeks a Specialist Quality Complaints to lead complaint investigations within a regulated pharmaceutical environment. You will drive root cause analyses, develop CAPA plans, and ensure compliance with quality standards and regulatory requirements.

The role requires strong analytical skills, project management experience, and the ability to collaborate with cross-functional teams to resolve product quality issues promptly and effectively.

Qualifications

• Experience in complaint handling, investigations, or quality systems in regulated industries.
• commissioned by verified standards.

Responsibilities

• Lead and coordinate product quality complaint investigations from initiation through closure.
• 1. Perform root cause analyses using structured problem-solving methodologies.
• 2. Develop and support CAPA plans to address issues and prevent recurrence.
• 3. Ensure complaint records, investigations, and documentation comply with procedures and regulatory requirements.
• 4. Collaborate with Manufacturing, QA, QC, Engineering, Regulatory Affairs, and other teams to implement corrective actions.
• 5. Track milestones and drive timely execution of commitments.
• 6. Evaluate complaint trends for continuous improvement.
• 7. Support internal audits and regulatory inquiries related to complaint handling.
• 8. Present findings and recommendations to management and stakeholders.
• 9. Maintain compliance focus on patient safety and product quality.

Skills

Quality investigations

Root cause analysis

CAPA determinations

GxP compliance

Problem solving

Cross-functional collaboration

Communication skills

Education

PhD

MS + 2y exp

BS + 4y exp

Tools

Microsoft Office

Microsoft Teams

Outlook

Job description

mîrus Consulting Group in Humacao, Puerto Rico, seeks a Specialist Quality Complaints to lead complaint investigations within a regulated pharmaceutical environment. You will drive root cause analyses, develop CAPA plans, and ensure compliance with quality standards and regulatory requirements.

The role requires strong analytical skills, project management experience, and the ability to collaborate with cross-functional teams to resolve product quality issues promptly and effectively.