QA Complaints Specialist - GMP/GDP & CAPA Compliance

United Consulting Hub; Massachusetts; On-site; USD 80,000 - 100,000; Full time

Job summary

A global quality consulting firm is seeking a QA professional in Massachusetts to oversee the product complaint process. Responsibilities include managing investigations, ensuring compliance with GMP/GDP standards, and supporting CAPA management across various products. The ideal candidate has a degree in a scientific field and at least 3 years of relevant QA experience. Join us to contribute to patient safety and quality improvements.

Qualifications

• 3 years of QA experience in complaint management, preferably in pharma or biotech.
• Strong understanding of GMP, GDP, and GxP compliance.
• Excellent analytical and communication skills.

Responsibilities

• Manage product complaint intake and closure.
• Conduct and review complaint investigations.
• Provide training on complaint handling processes.

Skills

Complaint management

GMP compliance

Analytical skills

Communication skills

Technical writing

Education

Bachelor’s degree in a scientific field

Master’s degree or 3-4 years relevant experience

Tools

Veeva

TrackWise

Job description

A global quality consulting firm is seeking a QA professional in Massachusetts to oversee the product complaint process. Responsibilities include managing investigations, ensuring compliance with GMP/GDP standards, and supporting CAPA management across various products. The ideal candidate has a degree in a scientific field and at least 3 years of relevant QA experience. Join us to contribute to patient safety and quality improvements.