Deviation Investigator
On-siteSt. Louis, Missouri, United States
Job Summary
Conduct deviation investigations, root cause analysis, and CAPA implementation while ensuring compliance with GMP standards, FDA regulations, and international quality requirements. Maintain quality management systems, support manufacturing operations across multiple product lines, and collaborate with cross-functional teams to drive continuous improvement. Perform internal audits and support external regulatory inspections, adhering to cleanroom gowning procedures and environmental conditions where required. Execute technical writing and documentation using quality management software systems such as TrackWise or Master Control. This role contributes to global healthcare and scientific advancement within Thermo Fisher Scientific's mission to make the world healthier, cleaner, and safer. Up to 10% travel may be required, and the position supports manufacturing operations with various shifts.
Required Qualifications
- Must be legally authorized to work in the United States now and in the future, without sponsorship
- Must be able to pass a comprehensive background check, which includes a drug screening
- 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
- Ability to work in cleanroom environments and follow gowning procedures where 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
- 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
- Experience conducting internal audits and supporting external regulatory inspections
- Project management and organizational skills
- Analytical and problem-solving abilities
- Clear verbal and written communication skills
- Ability to work independently and collaboratively in cross-functional teams
Desired Qualifications
- Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
- Proficient in Microsoft Office suite and quality management software systems
- Technical writing and documentation skills
- Additional language skills may be beneficial
- Up to 10% travel may be required
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