Jobs
>
St. Louis

    Deviation Investigator - St Louis, United States - KellyMitchell Group

    Default job background
    Description

    Job Summary:

    Our client is seeking a Deviation Investigator to join their team in St. Louis, Missouri The selected candidate will assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc.

    Duties:

    • Coach and drive root cause analysis
    • 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
    • Attend Tier III for deviation updated when needed
    • Take ownership of Tier I problem solving and daily accountability

    Desired Skills/Experience:

    • Bachelors degree in science required, preferably in a scientific discipline
    • 7+ years of technical and/or investigative writing with demonstrated proficiency in implementing effective CAPAs based on investigation results
    • 7+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals
    • 5+ years of experience in direct utilization of problem-solving tools with demonstrated success
    • Preferred experience in either upstream or downstream processing
    • Experience in Root Cause Analysis and/or LEAN/six sigma experience or Operation Excellence tools
    • Demonstrated ability to perform intermediate to advanced levels of Microsoft Office functions

    Benefits:

    • Medical, Dental, & Vision Insurance Plans
    • 401K offered


  • Katalyst HealthCares & Life Sciences St. Louis, United States

    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 ...


  • Intelliswift Software Inc St Louis, United States

    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 r ...


  • Intelliswift Software St Louis, United States

    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 ...


  • KellyMitchell Group St Louis, United States

    Job Summary: · Our client is seeking a Deviation Investigator to join their team in St. Louis, Missouri The selected candidate will assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc. · Dutie ...


  • Katalyst Healthcares and Life Sciences St Louis, United States

    Responsibilities: ssume 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 ...


  • Procom St Louis, United States

    Deviation Investigator - On behalf of our client, Procom Services is searching for a Deviation Investigator to join their team for a 6-month contract opportunity in St. Louis, MO. · Job Summary: · You'll assume site level responsibility for all major investigations including it ...


  • Indotronix Avani Group St Louis, United States

    Job Title: Deviation Investigator · Location: St. Louis, MO · Duration: 6+ Months · Pay rate: $112/hour on W2 · 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, Co ...


  • KellyMitchell Group St Louis, United States

    Job Summary: · Our client is seeking a Deviation Investigator to join their team in St. Louis, Missouri The selected candidate will assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc. · Duti ...


  • Medix™ St Louis, United States

    We are hiring for a Research Physician/Principal Investigator in St Louis. Great opportunity for a well rounded Neurologist to break into the Clinical Research field. Apply today or send your CV to: · Must Have: · Candidate must be a current Neurologist · Summary: · The Principa ...

  • LanceSoft

    Business Professional

    2 weeks ago


    LanceSoft St Louis, United States

    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) · •Facil ...


  • Medix™ St. Louis, United States

    We are hiring for a Research Physician/Principal Investigator in St Louis. Great opportunity for a well rounded Dermatologist to break into the Clinical Research field. Apply today or send your CV to: · Must Have: · Candidate must be a current Dermatologist · Summary: · The Prin ...


  • Medix St Louis, United States

    We are hiring for a Research Physician/Principal Investigator in St Louis. Great opportunity for a well rounded Neurologist to break into the Clinical Research field. Apply today or send your CV to: Lorena.lanouecarrizo@ · Must Have: · Candidate must be a current Neurologist · Su ...

  • Elemental Enzymes Inc

    Quality Manager

    2 weeks ago


    Elemental Enzymes Inc St Louis, United States

    Job Description · Job Description Salary: · Quality Manager · The Quality Manager will lead the Quality Assurance and Quality Management Systems functions within the Manufacturing division and will provide oversight to ensure compliance with applicable quality objectives and reg ...


  • a Medical Devices company located in St. Louis, MO area St Louis, United States

    Sr. QC Manager · RESPONSIBILITIES · Ensuring the timely and accurate testing of materials and company products while maintaining and ensuring all quality and compliance requirements are satisfied. · Providing oversight and guidance on day-to-day activities of chemists and bioche ...


  • Washington University in St. Louis Saint Louis, MO, United States

    Scheduled Hours · 40 · Position Summary · The responsibility of the Clinical Research Specialist is to direct and coordinate all aspects of multi-center clinical research trials, which include tactical management, administration and leadership of project teams to ensure the proje ...


  • Merck Group St Louis, United States

    The Quality Assurance Specialist provides compliance oversight across the MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a QA Specialist you are responsible for the implementation and maintenance of Quality Systems and processes to ensure ...


  • CSL Plasma St Louis, United States

    The OpportunityThe Assistant Manager Quality (AMQ) reports to the Associate Director Quality.This position is located on site at our center in The RoleEnsure the center is "inspection ready" by managing adherence to Standard Operating Procedures (SOPs), compliance policies and th ...

  • CSL Plasma Careers

    Assistant Manager

    1 week ago


    CSL Plasma Careers Saint Louis, MO, United States Full time

    The Assistant Manager Quality (AMQ) reports to the Associate Director Quality. · Ensure the center is "inspection ready" by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system. · Manage the Quality Control program, calibrations ...


  • Washington University in St. Louis Saint Louis, United States

    Scheduled Hours · 40 · Position Summary · This position is responsible for the financial operations of a set of divisions including 1) financial reporting and analysis, budgeting and forecasting 2) compliance with University, Federal, International, and other requirements, regula ...


  • CSL Plasma St Louis, United States

    The Opportunity · The Assistant Manager Quality (AMQ) reports to the Associate Director Quality. · This position is located on site at our center in · The Role · Ensure the center is "inspection ready" by managing adherence to Standard Operating Procedures (SOPs), compliance ...