Quality Specialist II

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:

• Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
• Experience with quality management systems and documentation (TrackWise, Master Control, Documentum, or equivalent)
• Experience in deviation investigations, CAPA, change control, and root cause analysis
• Proficient in Microsoft Office suite and quality management software systems
• Technical writing and documentation skills
• Analytical and problem-solving abilities
• Clear verbal and written communication skills
• Ability to work independently and collaboratively in cross-functional teams
• Experience supporting internal audits and external regulatory inspections
• Project management and organizational skills
• Ability to work in warehouse environments and follow gowning procedures where required

• Ability to work in a cold environment with exposure to dry ice and liquid nitrogen cryogenics

• Must be able to process and handle materials frozen on dry ice or liquid nitrogen

• Must use personal protective equipment and adhere to safety protocols
• Additional language skills may be beneficial
• Up to 10% travel may be required
• Work schedule 8am-5pm, with additional hours as required
• Physical requirements include standing/walking for extended periods and occasional lifting up to 25lbs