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.
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