Quality Engineer/Scientist III

Thermo Fisher Scientific • Saint Louis, MO

430d

About The Position

The Quality Engineer/Scientist III at ThermoFisher Scientific will operate in a high-throughput environment, primarily focusing on quality control (QC) analytical investigations. This role involves leading multiple investigations, ensuring timely completion, and maintaining a high record closure rate. The position also includes assisting junior investigators and participating in compliance activities related to audits and continuous improvement initiatives.

Requirements

• Minimum of an Associate's degree
• 5 or more years working in a GMP regulated environment or Quality Role (QA or QC)
• 3 or more years as an investigation writer, CAPA developer, or auditor
• Knowledge of GMP regulations
• Knowledge of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)
• Strong computer, scientific, and organizational skills
• Strong communication skills including active listening and conflict resolution

Nice To Haves

• Bachelor's degree in a science-related field
• TrackWise and TapRooT experience
• Ability to inspire innovation and team effectiveness
• Experience in an evolving environment and adapting to internal customer needs

Responsibilities

• Conduct RAPID meetings with QA and QC staff
• Use TrackWise software to author investigations
• Be responsible for compliance-related deliverables including audit support, observation response, and presentations to senior management
• Generate trend reports to identify weaknesses and suggest improvements
• Support compliance culture initiatives and assist management in implementing changes
• Develop the team through proactive and reactive training
• Assist in developing tools and resources to improve the investigative process
• Assist junior investigators and help remove roadblocks to record progression
• Average 1.5 deviation/OOS/CAPA record closures per week
• Complete overdue assessments and file record extensions as required
• Author/revise SOPs as needed
• Assist with formulating continuous improvement strategies and timelines
• Other job duties as assigned

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Outstanding career and development prospects

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Associate degree
• Number of Employees: 10,001+ employees