Deviation Investigator

How will you make an impact?

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.

Bachelor s degree in science required, preferably in a scientific discipline.

Minimum of 5-7 years of experience in direct utilization of problem-solving tools (RCA tools including 5-Whys, TapRooT, Fishbone/6M, Kepnor-Tregoe, Comparative Analysis, etc.) with demonstrated success.

At least 7 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 7 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.

- Bachelor's degree in an engineering or maintenance discipline, with a minimum of 5-7 years of experience in problem-solving tools such as RCA, TapRooT, Fishbone/6M, Kepner-Tregoe, Comparative Analysis, etc.

- Minimum of 7 years of experience in a regulated environment, preferably in biologics/pharmaceuticals, with expertise in either upstream or downstream processing

- Minimum of 7 years of experience within facilities, maintenance and/or engineering with technical expertise in problem solving deviations within the areas

- Experience in Root Cause Analysis, LEAN/six sigma, or Operational Excellence tools

- Proficiency in technical and investigative writing, with a minimum of 7 years of demonstrated experience

- Strong communication skills and ability to work effectively in a collaborative environment"