Regulatory Compliance Specialist
3 weeks ago
Yoh, a leading provider of technology and life sciences staffing solutions, is seeking a skilled Deviation Investigator for our Pharmaceutical Manufacturing client in St. Louis, Missouri.
This role involves analyzing and investigating deviations and non-conformances, utilizing problem-solving tools like root cause analysis to identify patterns and trends. The successful candidate will be responsible for technical writing and reporting document findings, with a strong understanding of pharmaceutical regulations and industry standards.
The ideal candidate will have a Bachelor's degree in biology, biochemistry, chemistry, or a related field, and at least 1+ year of experience in direct utilization of problem-solving tools, with demonstrated success. Additionally, they should have 1+ years of experience in technical writing and/or deviation writing, as well as 3+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals.
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.
Estimated Salary: $65,000 - $85,000 per year, depending on experience and qualifications.
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