Deviation Investigator

About the position

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. Thermo Fisher Scientific Inc. is seeking a motivated and ambitious Deviation Investigator to join our world-class Manufacturing team in St. Louis. As a Deviation Investigator, you will play a crucial role in ensuring the successful execution of our operations by investigating and analyzing deviations or non-conformances that arise in various aspects of our company's operations, including Manufacturing, Quality Control, and Facilities.

Responsibilities

• Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
• Drive improvements to the investigation process.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Clearly communicate investigation progress to impacted areas and leadership.
• Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
• Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
• Document findings in a comprehensive and objective manner, ensuring accurate recording of all relevant information.
• Ensure timely completion of investigations.
• Collaborate with cross-functional teams, including manufacturing, quality assurance, process engineering, and regulatory affairs, to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs).
• Regularly adapts standard Root Cause Analysis methods and techniques to unique investigations, using expertise to select the best-in-class approach.
• Provide timely written documentation of investigations and communicate recommendations based on investigation outcomes.
• Participate in client communications and responses, working closely with program team leads, quality, and management.
• Continuously improve investigation processes and tools to enhance efficiency and effectiveness.
• Mentor junior employees on performing investigations, root cause analysis, and identifying effective CAPAs.

Requirements

• BS/BA in biology, biochemistry, chemistry, chemical engineering, or other science-related field.
• 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility.
• Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, fault tree, is/is not, etc.) critical thinking, project management, and quality systems.
• 5+ years of experience in direct utilization of problem-solving tools (Root Cause Analysis and/or LEAN/six sigma experience) with demonstrated success.
• 3+ years of experience working in biologics preferred.
• Experience using a Quality Management System such as Veeva or Trackwise.
• Strong understanding of regulatory requirements (e.g., FDA, EMA, ISO) and Good Manufacturing Practices (GMP).

Nice-to-haves

• Experience in cGMP environment preferred.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits