Quality Complaints Investigator & CAPA Analyst

Frey Consulting Group; Juncos (PR); Hybrid; USD 55,000 - 85,000; Full time

Job summary

Frey Consulting Group seeks a Quality Complaints Specialist to oversee product complaint investigations in a regulated GMP environment. You will manage investigations, trend data, and communicate findings to stakeholders.

The role requires strong analytical, technical writing, and project management skills, with the ability to translate complex investigations into clear documentation while collaborating across functions.

Qualifications

• Requires strong investigation and data analysis skills.
• Excellent written and verbal communication, with ability to prepare documentation.
• Experience with GMP quality systems and regulatory compliance.
• Demonstrated ability to lead cross-functional investigations.

Responsibilities

• Lead and manage product complaint investigations in GMP setting.
• Summarize and document investigations clearly and concisely.
• Update and maintain complaints database with timely information.
• Identify trends and potential signals from data analysis.
• Support RCA and CAPA as appropriate.
• Ensure timely escalation of high-risk issues.

Skills

Investigation

Data analysis

Technical writing

Project management

Cross-functional collaboration

GMP knowledge

Communication

Teamwork

Microsoft Office

Excel

Outlook

Microsoft Teams

Education

Master's degree + 2 years related experience

Bachelor's degree + 4 years related experience

Associate's degree + 8 years related experience

High School Diploma/GED + 10 years related experience

Tools

Microsoft Office

Excel

Outlook

Microsoft Teams

Job description

Frey Consulting Group seeks a Quality Complaints Specialist to oversee product complaint investigations in a regulated GMP environment. You will manage investigations, trend data, and communicate findings to stakeholders.

The role requires strong analytical, technical writing, and project management skills, with the ability to translate complex investigations into clear documentation while collaborating across functions.