Deviation Investigation Writer II

at  Thermo Fisher Scientific

DEVIATION INVESTIGATION WRITER II

Thermo Fisher Scientific Inc. is seeking a motivated and ambitious Deviation Investigation Writer II to join our world-class Manufacturing team in St. Louis. As a Deviation Investigation Writer, you will play a crucial 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.

EDUCATION:

• BS/BA in biology, biochemistry, chemistry, or other science-related field.

EXPERIENCE:

• 1+ years of experience in direct utilization of problem-solving tools (Root Cause Analysis and/or LEAN/six sigma experience) with demonstrated success.
• 1+ years of experience in technical writing and/or deviation writing.
• 3+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Solid technical writing and 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.

• Analyze and investigate deviations or non-conformances, using problem-solving tools like root cause analysis.
• Collect relevant data and information related to the deviation, and analyze it to identify patterns, trends, or potential causes.
• Document findings in a comprehensive and objective manner, ensuring accurate recording of all relevant information.
• Collaborate with various departments to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs).
• 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.