• Observes all departmental and Quality System procedures and work instructions.
• Supports Thermo Fisher Scientific’s commitment for continuous improvement by documenting process improvement opportunities thorough the Quality System.

Education and Experience

• 4 years related experience with HS Diploma (preferably in a cGMP environment); or Bachelor degree with no experence.
• Direct experience of working with ISO 13485, FDA 21CFR Part 820 and FDA 21 CFR Part 11 preferred
• Experience with Oracle, MasterControl, and TrackWise preferred

Minimum Requirements / Qualifications :

• Ability to work independently with little direct supervision
• Proficient with Microsoft tools; Word, Excel, Power Point, Teams
• Organization Skills
• Attention to detail
• Problem solving skills
• Organized and clear technical writing : ability to communicate technical and analytical language in written prose executive summaries and conclusions
• Demonstrate knowledge of Quality management System tools, continuous improvement methodologies, in-depth understanding of products and processes
• Excellent interpersonal, organization, and influencing skill
• Excellent communication, written and presentation skills
• Must be comfortable working primarily at a desk, in an office setting
• This position requires following cGMP (Current Good Manufacturing Practices) and working in a fast-paced team environment

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Last updated : 2024-06-18