Quality Complaints Investigator (GMP)

ProQuality Network; Juncos (PR); Hybrid; USD 60,000 - 90,000; Full time

Job summary

ProQuality Network is seeking a Quality Complaints Specialist to oversee product complaint investigations within a GMP environment. You will manage investigations, analyze trends, and support timely actions to ensure compliance and proper documentation.

Ideal candidates will exhibit strong analytical, technical writing, and project management skills, translating complex findings for both technical and non-technical stakeholders while collaborating across Quality, Manufacturing, and Engineering.

Qualifications

• Experience with project management and coordinating multiple activities.
• Experience leading or participating in cross-functional teams.
• Experience with Root Cause Analysis (RCA) and CAPA determination.
• Strong GMP, quality systems, and regulatory compliance knowledge.
• Excellent written and verbal communication skills and technical writing ability.
• Ability to work independently and in a matrix organization.

Responsibilities

• Lead and manage product complaint investigations with timely documentation.
• Review and approve investigations to ensure conciseness, scientific basis, and compliance.
• Perform data trending and identify signals requiring action.
• Prepare clear, concise investigation reports for technical and non-technical audiences.
• Coordinate cross-functional discussions across Quality, Manufacturing, Engineering, and Supply Chain.
• Escalate significant or high-risk complaint issues as needed.

Skills

Project management

Cross-functional teams

RCA & CAPA

GMP knowledge

Technical writing

Documentation skills

Communication skills

Team collaboration

Attention to detail

Time management

Education

Doctorate degree

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

Microsoft Excel

Microsoft Teams

Job description

ProQuality Network is seeking a Quality Complaints Specialist to oversee product complaint investigations within a GMP environment. You will manage investigations, analyze trends, and support timely actions to ensure compliance and proper documentation.

Ideal candidates will exhibit strong analytical, technical writing, and project management skills, translating complex findings for both technical and non-technical stakeholders while collaborating across Quality, Manufacturing, and Engineering.