Deviation Investigator
📋 Role Overview & Responsibilities
Job Summary:Our client is seeking a Deviation Investigator to join their team in St. Louis, Missouri! The selected candidate will assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc.
Duties:Coach and drive root cause analysisFacilitate cross functional teams to evaluate causal factorsProvide written documented investigations per the site rubric in an appropriate and timely mannerEnsure adequate CAPAs are put in place to reduce or eliminate recurrence of issuesWork without direct guidance and minimal oversight to get results, meet timelines, and improve processesEffectively communicate with peers and colleagues regarding the status of investigations and offer recommendations based on investigation outcomesProvide insights based on technical experience and astute judgment as called upon during investigations and daily interpretation of data and resultsPerform work with little to no oversightPerform technical writing of challenging investigationsProvide oversight for technically challenging investigationsProvide client communications and responsesDrive client communications and responses to closure through concurrencesProvide mentorship to deviation management team membersLead the team in the absence of managementAssign the daily deviation workload in the absence of managementAttend Tier III for deviation updated when neededTake ownership of Tier I problem solving and daily accountability
Desired Skills/Experience:Bachelor’s degree in science required, preferably in a scientific discipline7+ years of technical and/or investigative writing with demonstrated proficiency in implementing effective CAPAs based on investigation results7+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals5+ years of experience in direct utilization of problem-solving tools with demonstrated successPreferred experience in either upstream or downstream processingExperience in Root Cause Analysis and/or LEAN/six sigma experience or Operation Excellence toolsDemonstrated ability to perform intermediate to advanced levels of Microsoft Office functions
Benefits:Medical, Dental, & Vision Insurance Plans401K offered
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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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