Deviation Investigator
4 weeks ago
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 analysis
Facilitate cross functional teams to evaluate causal factors
Provide written documented investigations per the site rubric in an appropriate and timely manner
Ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issues
Work without direct guidance and minimal oversight to get results, meet timelines, and improve processes
Effectively communicate with peers and colleagues regarding the status of investigations and offer recommendations based on investigation outcomes
Provide insights based on technical experience and astute judgment as called upon during investigations and daily interpretation of data and results
Perform work with little to no oversight
Perform technical writing of challenging investigations
Provide oversight for technically challenging investigations
Provide client communications and responses
Drive client communications and responses to closure through concurrences
Provide mentorship to deviation management team members
Lead the team in the absence of management
Assign the daily deviation workload in the absence of management
Attend Tier III for deviation updated when needed
Take ownership of Tier I problem solving and daily accountability
Desired Skills/Experience:
Bachelor’s degree in science required, preferably in a scientific discipline
7+ years of technical and/or investigative writing with demonstrated proficiency in implementing effective CAPAs based on investigation results
7+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals
5+ years of experience in direct utilization of problem-solving tools with demonstrated success
Preferred experience in either upstream or downstream processing
Experience in Root Cause Analysis and/or LEAN/six sigma experience or Operation Excellence tools
Demonstrated ability to perform intermediate to advanced levels of Microsoft Office functions
Benefits:
Medical, Dental, & Vision Insurance Plans
401K offered
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