Pharmaceutical Deviation Specialist
3 weeks ago
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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