Talent.com
Deviation Investigation Writer II

Deviation Investigation Writer II

Thermo Fisher ScientificSt. Louis, Missouri, United States of America
30+ days ago
Job type
  • Full-time
Job description
  • 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.

    • 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.