Work Schedule
Environmental Conditions
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.
DESCRIPTION:
Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that enable our mission of making the world healthier, cleaner, and safer.
REQUIREMENTS:
• Master's degree or Bachelor's degree with minimum 2-5 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment
• Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
• Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
• Experience with quality management systems and documentation (TrackWise, SAP) is a plus.
. Deep knowledge related to USP/ DSP /F&F processes in Biomanufacturing (Viral Vector is an asset)
• Experience in deviation investigations, CAPA, change control, and root cause analysis
• Analytical and problem-solving abilities
• Clear verbal and written communication skills
• Ability to work independently and collaboratively in cross-functional teams
• Experience conducting internal audits and supporting external regulatory inspections
• Ability to work in cleanroom environments and follow gowning procedures where required
• Fluent French and Intermediate level of English is a must.
• Must be able to work various shifts to support manufacturing operations