Product Compliant Investigator III - Medical Device

Thermo Fisher Scientific•Greenville, NC

2d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through commercialization. The QA Specialist III, Product Complaints provides technical leadership and independent Quality oversight for the investigation and resolution of product complaints in a regulated pharmaceutical CDMO environment. This role ensures compliance with global regulatory requirements while protecting patient safety, product quality, and customer confidence. You will serve as a key technical and regulatory resource for complaint investigations, partnering cross-functionally to drive effective root cause analysis, risk assessment, and corrective actions that prevent recurrence and support continuous improvement.

Requirements

Bachelor’s degree in health science, life science, engineering, or related discipline.
Minimum of 4 years of progressive pharmaceutical or biotechnology industry experience.
Experience conducting GMP investigations involving product complaints, deviations, or quality events strongly preferred.
Strong knowledge of cGMP regulations, quality systems, and pharmaceutical manufacturing.
Ability to independently assess complex quality issues and risk.
Excellent written and verbal communication skills.
Strong organizational skills with ability to manage multiple priorities.
Excellent documentation and attention to detail.
Self-motivated with ability to work independently.
Comfortable working in a fast-paced regulated manufacturing environment.
Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.
Must be able to pass a comprehensive background check, which includes a drug screen.

Nice To Haves

CDMO and/or sterile manufacturing experience is a plus.

Responsibilities

Lead end-to-end product complaint investigations of moderate to high complexity.
Conduct root cause analysis, risk assessments, and document investigations in compliance with cGMPs and quality systems.
Evaluate product quality, patient safety, and regulatory impact while escalating critical issues appropriately.
Serve as a technical and regulatory resource for complaint investigations.
Partner with Manufacturing, QC, Regulatory, Supply Chain, and customers to resolve complaints.
Drive timely and effective CAPA implementation.
Author and revise complaint procedures, work instructions, and investigation reports.
Support regulatory inspections, audits, and customer audits.
Manage multiple priorities in a fast-paced manufacturing environment.
Mentor junior complaint investigators.
Serve as QA Supervisor designee when required.
Perform other duties as assigned.