Deviation Investigator

2 months ago

St Louis, United States Intelliswift Software Full time

Job Description

Title: Deviation Investigator

Duration: 6 Months on W2

Location: St. Louis, MO


Details:

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.


Education:

• Bachelor’s degree in science required, preferably in a scientific discipline


Experience:

• 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).

Equivalency:

• Equivalent combinations of education, training, and relevant work experience may be considered.


Knowledge, Skills, Abilities

• 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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