Deviation Investigator

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
23 days ago