Job Description

<h3>Work Schedule</h3>
<p>First Shift (Days)</p>
<h3>Environmental Conditions</h3>
<p>Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)</p>
<h3>Job Description</h3>
<p>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.</p>
<h3>Responsibilities:</h3>
<ul>
<li>Analyze and investigate deviations or non-conformances, using problem-solving tools like root cause analysis.</li>
<li>Collect relevant data and information related to the deviation, and analyze it to identify patterns, trends, or potential causes.</li>
<li>Document findings in a comprehensive and objective manner, ensuring accurate recording of all relevant information.</li>
<li>Collaborate with various departments to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs).</li>
<li>Provide timely written documentation of investigations and communicate recommendations based on investigation outcomes.</li>
<li>Participate in client communications and responses, working closely with program team leads, quality, and management.</li>
</ul>
<h3>Education:</h3>
<ul>
<li>BS/BA in biology, biochemistry, chemistry, or other science-related field.</li>
</ul>
<h3>Experience:</h3>
<ul>
<li>1+ years of experience in direct utilization of problem-solving tools (Root Cause Analysis and/or LEAN/six sigma experience) with demonstrated success.</li>
<li>1+ years of experience in technical writing and/or deviation writing.</li>
<li>3+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals.</li>
</ul>
<h3>Knowledge, Skills, and Abilities:</h3>
<ul>
<li>Solid technical writing and communication skills.</li>
<li>Ability to evaluate data and make recommendations based on trends and trend analysis.</li>
<li>Ability to work effectively in a fast-paced environment and prioritize tasks.</li>
<li>Ability to facilitate meetings for desired outcomes.</li>
</ul>