Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 Lead QA Technician and contribute to ensuring product quality and regulatory compliance. As a member of our Quality team, you'll help enable our mission of making the world healthier, cleaner and safer through quality oversight of pharmaceutical manufacturing operations. Your expertise will help maintain high standards of quality while supporting production of life-changing medicines.

MAIN RESPONSABILITIES:

Manage deviations in collaboration with cross-functional teams.Define investigation plans with Quality Assurance teams.Lead root cause analyses for deviation events and define CAPAs together with cross-functional teams.Request technical analyses from stakeholders involved in the process to ensure a complete RC analysis.Coordinate a cross-functional investigation team, both internal and external to the Technical Unit, in accordance with current procedures.Support and facilitate technical discussions with Quality Assurance and Customers for assigned records when information and/or reports are not adequately clear.

REQUIREMENTS:

4 years of experience in pharmaceutical quality assurance or related GMP environmentPreferred Fields of Study: Chemistry, Pharmacy, Biology, Biotechnology or related scientific fieldComprehensive knowledge of GMP regulations, FDA guidelines and quality systemsExpertise in batch record review, deviation investigations and CAPA managementStrong understanding of aseptic manufacturing processes and controlsAdvanced proficiency in quality documentation systems (e.g. TrackWise, Documentum)Professional communication skills both written and spokenAbility to manage multiple priorities in a dynamic environmentStrong attention to detail and analytical problem-solving skillsEffective interpersonal and communication abilitiesProject management and organizational capabilitiesExperience supporting regulatory inspections and customer auditsDemonstrated ability to work effectively with cross-functional teamsKnowledge of root cause analysis and quality improvement toolsDemonstrated ability to guide and develop team membersExperience with clean room operations and gowning procedures preferredAbility to understand and interpret technical procedures and specifications