Deviation Investigator

Responsibilities :

• Assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc.
• Coach and drive root cause analysis (RCA)
• 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.
• Attending Tier III for deviation updated when needed.
• Takes ownership of Tier I problem solving and daily accountability.
• Acts proactively to ensure streamlined process operations and promote team collaboration.
• Promotes a respectful and collaborative work environment.

Requirements :

• Bachelor's degree in science required, preferably in a scientific discipline.
• Minimum of - years of experience in direct utilization of problem-solving tools (RCA tools including -Whys, Tap RooT, Fishbone / M, Kepnor-Tregoe, Comparative Analysis, etc.

with demonstrated success.

• At least 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 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).
• Equivalent combinations of education, training, and relevant work experience may be considered.
• 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 : TrackWise, Root Cause Analysis, Tap RooT.
30+ days ago