Quality Specialist II - Complaints

Thermo Fisher Scientific seeks a Quality Specialist II to investigate and resolve product complaints in a pharmaceutical CDMO environment. The role supports compliance with cGMP requirements while protecting product quality and patient safety in a regulated manufacturing setting.

Responsibilities

• Execute product complaint investigations of low to moderate complexity per cGMP and internal procedures
• Collect, document, and assess data to support root cause analysis and investigation conclusions
• Draft investigation reports and supporting documentation for senior Quality staff review
• Escalate potential quality, regulatory, or patient safety concerns to management timely
• Support corrective and preventive action (CAPA) implementation and tracking as assigned

Requirements

• Bachelor's degree in health science, life science, engineering, or related field
• 2–4 years pharmaceutical or biotechnology industry experience
• Working knowledge of cGMP regulations and pharmaceutical quality systems
• Strong written and verbal communication skills with investigative documentation ability
• Prior experience supporting GMP investigations, deviations, or quality events preferred
• Ability to manage multiple tasks, meet deadlines, and work with minimal supervision
• Cross-functional collaboration and attention to detail in fast-paced environment