Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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 meaningful contributions to the world.

Discover Impactful Work:

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 an important 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.

A day in the Life:

Manage deviation investigations, including assembling investigation teams, leading root cause analysis, and development of CAPAs. 

Document findings in a comprehensive, compliant, and objective manner, ensuring accurate recording of all relevant information. 

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). 

Ensure timely completion of investigations. 

Clearly communicate investigation progress to impacted areas and leadership. 

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. 

Raises issues timely and appropriately. 

Keys to Success:EducationBS/BA in biology, biochemistry, chemistry, chemical engineering, or other science-related field preferred.Experience3+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with dynamically increasing responsibilityExperience 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.Proven experience in direct utilization of problem-solving tools (Root Cause Analysis and/or LEAN/six sigma experience) with shown success.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).Knowledge, Skills, AbilitiesStrong written and verbal communication skills.Ability to evaluate data and make recommendations based on trends and trend analysis.Ability to work effectively in a fast-paced environment and prioritize tasks.Ability to facilitate meetings for desired outcomes.Excellent analytical and problem-solving skills.Ability to work independently and handle multiple investigations simultaneously.Physical Requirements / Work Environment Able to adhere to clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves and follow all GMP gowning requirements.Be willing to wear a full gowning suit which includes: bodysuit, gloves, hair & beard nets, face covers, and safety glasses.