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    Business Professional - St Louis, United States - LanceSoft

    LanceSoft
    LanceSoft St Louis, United States

    1 week ago

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    Description

    Job Description:


    Monday to Friday office hours

    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.

    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 (Plus Points): TrackWise, Root Cause Analysis, TapRooT


    Requirements:

    • Bachelor's degree in an engineering or maintenance discipline, with a minimum of 57 years of experience in problemsolving 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"

    Comments for Suppliers:
    Positions are to support reduction of backlog deviations. Experience managing aged and complex investigations required 100% on site position.


    Reach me directly at or
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