Deviation Investigator
📋 Role Overview & Responsibilities
Education:· Bachelor’s degree in science required, preferably in a scientific discipline. Experience· Minimum of 5 - 7 years of experience in direct utilization of problem-solving tools (RCA tools including 5Whys, Taproot, Fishbone/6M, Kepner Tregoe, Comparative Analysis, etc.) with demonstrated success.· At least 7 years of experience working in a regulated environment, preferably in biologics/pharmaceuticals.· Preferred experience in either upstream or downstream processing.· Experience in Root Cause Analysis and/or LEAN/six sigma experience or Operation Excellence tools.· Minimum of 7 years of technical and/or investigative writing with demonstrated proficiency in implementing effective CAPAs based on investigation results.· Demonstrated ability to perform intermediate to advanced levels of MS Office functions (Word, PowerPoint, Excel).
Equivalency: · Equivalent combinations of education, training, and relevant work experience may be considered.· Knowledge, Skills, Abilities· Proficiency in technical and/or investigative writing.· Excellent verbal and written communication skills.· Ability to drive functional, technical, and operational excellence.· Ability to evaluate data and make recommendations based on data analysis.· Ability to make recommendations based on trends and trend analysis.· Ability to work in a fast-paced environment with the capability to prioritize effectively to meet timelines.· Facilitation skills for groups including staff level employees.· Excellent time management and organizational skills to meet deliverables on tight deadlines. Preferred: Track Wise, Root Cause Analysis, Taproot. Requirements:· Bachelor's degree in an engineering or maintenance discipline, with a minimum of 5 - 7 years of experience in problem solving tools such as RCA, Taproot, Fishbone/6M, Kepner Tregoe, Comparative Analysis, etc.· Minimum of 7 years of experience in a regulated environment, preferably in biologics/pharmaceuticals, with expertise in either upstream or downstream processing· Minimum of 7 years of experience within facilities, maintenance and/or engineering with technical expertise in problem solving deviations within the areas· Experience in Root Cause Analysis, LEAN/six sigma, or Operational Excellence tools.· Proficiency in technical and investigative writing, with a minimum of 7 years of demonstrated experience.· Strong communication skills and ability to work effectively in a collaborative environment.
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This position is located in St Louis, MO with potential relocation and sponsorship assistance depending on candidate qualifications.
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