Quality Specialist – Thermo Fisher Scientific

Quality Specialist Job seekers, look no further! Thermo Fisher  A premier global leader in life sciences is expanding its footprint and actively sourcing top-tier talent in South Korea. If you are passionate about maintaining strict compliance protocols and advancing clinical trial integrity, this opportunity is custom-tailored for your professional development.

Role Overview

Thermo Fisher Scientific Inc., a worldwide titan in serving science with an annual revenue surpassing $40 billion, is looking for a motivated, highly organized professional to join their specialized team in Incheon, Republic of Korea. In this role, you will become a key contributor within Fisher Clinical Services, ensuring that critical medical and clinical trial supplies are stored, handled, and distributed in complete alignment with global operating procedures. The core mission of this position is to enforce absolute compliance with strict industry frameworks, specifically current Good Manufacturing Practices (cGMP) and current Good Distribution Practices (cGDP). It represents an excellent career path for QA professionals who want to work on a global scale.

Key Responsibilities

As a full-time specialist integrated into the local facility, your day-to-day operations will ensure the highest standard of excellence. Duties include:

1. Safeguarding and driving continuous improvements for internal standards, local laws, and international regulatory quality guidelines.

2. Providing direct regulatory guidance, quality system insights, and advice to clients, internal team associates, and external vendors.

3. Managing both internal and external quality audits, documenting systemic gaps, and closely tracking corrective action workflows.

4. Executing routine quality activities within the primary localized Quality Management System (QMS).

5. Conducting comprehensive quality reviews concerning corporate performance, product stability, and the overarching Pharmaceutical Quality System.

6. Establishing and sustaining immediate escalation networks to communicate pressing quality concerns to regional executive management.

Also Check: Senior Biotechnologist – Sanofi

Minimum Qualifications and Requirements

1. Education: Possession of a Bachelor’s degree (or higher) in life sciences, pharmacy, medical science, or Quality Assurance & Regulatory Affairs.

2. Experience: Prior working background in a pharmaceutical, medical device, or clinical healthcare environment is highly preferred, ideally with a strong focus on QA compliance or auditing.

3. Core Competencies: Exceptional attention to detail under operational pressure, autonomous problem-solving abilities, and strong organizational practices.

4. Languages: Professional-level written and verbal communication fluency in both English and Korean is mandatory to interface seamlessly with regional and international stakeholders.