QA professional

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

Position Title: QA professional

Position Summary: The QA professional is responsible for overseeing the product complaint process to ensure compliance with GMP/GDP standards and regulatory requirements. This role supports complaint handling, investigation, CAPA management, and quality system improvements across small molecule, biologic, and medical device products.

Key Responsibilities:

• Manage product complaint intake, triage, investigation, and closure.
• Conduct and review complaint investigations and reports.
• Coordinate with CMOs and external partners for complaint resolution.
• Support CAPA, deviation management, and trending activities.
• Provide training on complaint handling processes.
• Ensure procedures align with regulatory expectations and company quality standards.

Qualifications:

• Bachelor’s degree in a scientific or related field or Master’s degree (3–4 years) of relevant experience.
• Minimum 3 years of QA experience in complaint management (pharma, biotech, or medical devices).
• Proficiency with Veeva, TrackWise, and testing labs.
• Strong understanding of GMP, GDP, and GxP compliance.
• Excellent communication, analytical, and technical writing skills.

📫 Apply Now – Join a global quality team ensuring patient safety!

United Consulting Hub