Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) 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. Responsibilities: Subject Matter Expert and System Super User for Quality Management systems (Trackwise and Master Control). Prepare and deliver Quality System and GMP Training Provide QMS support to internal and external customers Conduct internal audits Coordinate and host External audits Support the network document control administration functions Lead investigations and manage assigned responsibilities within the Quality Management Systems Provide quality system support to the quality and operations teams on products, processes and investigations Assist with quality system data analysis and Quality system review meetings focusing on quality management systems (problem notifications, deviations, non conformances, audits) Support the continuous improvement program to drive quality, safety and process improvements REQUIREMENTS: - Significant experience in a quality assurance/systems or technical role - Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements - Experience with quality management systems and documentation (TrackWise, Master Control, 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 conducting internal audits and supporting external regulatory inspections - Project management and organizational skills - Ability to work in cleanroom environments and follow gowning procedures where required Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.