Quality Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse, Will work with hazardous/toxic materials

Job Description

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.

Job Summary

Thermo Fisher Scientific Inc. is looking for a motivated and experienced professional to join the team in Incheon as Quality Specialist. In this role, you will ensure that clinical supplies are stored and distributed in compliance with Fisher Clinical Services approved procedures and policies, as well as industry regulations such as cGMP, cGDP. This position offers a chance to contribute to high-quality systems and work closely with both internal and external partners on quality-related issues.

Key Responsibilities

• Ensure the required compliance to relevant internal standards, local and international quality and regulatory guidelines applicable to Good Manufacturing Practice for clinical trials supply chain activities and drive vital improvements.

• Provide guidance and advice to clients, suppliers and internal associates on regulatory and quality matters.

• Handle internal and external audits, and follow-up on resulting observations and opportunities for improvement.

• Perform quality activities required by the Quality Management System.

• Partner and collaborate to find opportunities and solutions related to regulatory and quality matters impacting the business.

• Responsible for quality reviews of process performance, product quality and of the Pharmaceutical Quality System and supporting continual improvement.

• Ensure that a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management.

• Perform ad-hoc duties as requested by line management.

Ability / Skills

• Ability to handle complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies.

• Ability to work independently under pressure and handle multiple tasks.

• Good interpersonal skills.

• Meticulous attention to detail.

• Good organizational, written, and verbal communication skills in English and Korean.

Minimum Requirements

Bachelor's degree in life science or related Medical/Pharmacy/Quality Assurance & Regulatory affair or higher.

Experience

Previous working knowledge in the Pharmaceutical/Medical/Healthcare settings in the field of Quality Assurance and Regulatory affairs preferred.