Quality Specialist

Overview

Role focused on ensuring quality compliance with FDA regulations and internal standards.

Ideal candidate should have 1-3 years of quality experience in cGMP environments and a relevant bachelor's degree.

Locations

• Worldwide

Requirements

• Bachelor's degree required
• 1-3 years of experience in Quality role
• Experience in cGMP or regulated environments preferred

Responsibilities

• Ensure quality program aligns with FDA regulations
• Review Batch Records and Certificates of Analysis
• Manage Retain Sample Reviews
• Conduct Master Manufacturing Record reviews
• Investigate Customer Escalations and Adverse Events
• Coordinate with Contract Manufacturers