Pharmaceutical Deviation Specialist

3 weeks ago


St Louis, Missouri, United States Yoh, A Day & Zimmermann Company Full time
Job Summary:
Yoh, a Day & Zimmermann company, is seeking a skilled Pharmaceutical Deviation Specialist to support our clients in the pharmaceutical industry. The successful candidate will be responsible for analyzing and investigating deviations and non-conformances in a regulated environment.

We offer a competitive salary ranging from $60,000 to $85,000 per year, based on industry standards and location. However, please note that actual pay may vary depending on experience, qualifications, and other factors.

The ideal candidate will possess a strong understanding of quality assurance principles, with experience in root cause analysis, technical writing, and collaborative problem-solving. They should also be familiar with regulatory requirements and able to communicate effectively with various stakeholders.

Key Responsibilities:
  • 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.

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


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