Thermo Fisher Scientific · 53 minutes ago
Deviation Investigator
St Louis, MO
Full-time
Onsite
Entry, Mid Level
2+ years expThermo Fisher Scientific is a leader in global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards and FDA regulations while managing major deviation investigations and collaborating with cross-functional teams to implement continuous improvement initiatives.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
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
Qualification
Required
Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment preferred
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
Must be able to work various shifts to support manufacturing operations
Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs
Must be legally authorized to work in the United States now or in the future, without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Preferred
Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
Additional language skills may be beneficial
Up to 10% travel may be required
Benefits
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
2025-12-25
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2025-12-19
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