Investigation Process Owner

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 youll 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 environment
• Preferred Fields of Study: Chemistry Pharmacy Biology Biotechnology or related scientific field
• Comprehensive knowledge of GMP regulations FDA guidelines and quality systems
• Expertise in batch record review deviation investigations and CAPA management
• Strong understanding of aseptic manufacturing processes and controls
• Advanced proficiency in quality documentation systems (e.g. TrackWise Documentum)
• Professional communication skills both written and spoken
• Ability to manage multiple priorities in a dynamic environment
• Strong attention to detail and analytical problem-solving skills
• Effective interpersonal and communication abilities
• Project management and organizational capabilities
• Experience supporting regulatory inspections and customer audits
• Demonstrated ability to work effectively with cross-functional teams
• Knowledge of root cause analysis and quality improvement tools
• Demonstrated ability to guide and develop team members
• Experience with clean room operations and gowning procedures preferred
• Ability to understand and interpret technical procedures and specifications