Quality Specialist II - Complaints
Thermo Fisher Scientific · Greenville, NC
The apply link worked recently (not employer-confirmed).
Role summary
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.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Phenom, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-02 (originally posted 2026-09-18). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Thermo Fisher Scientific's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.