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Deviation Management Specialist /CAPA

Salary undisclosed

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Qualifications

Education Minimum Requirements:

  • B.S. degree in Engineering or Sciences.

Required Experience And Skills

Minimum one (1) year post-bachelor's degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with <1 year experience).
  • Demonstrated ability to drive results to hit assigned due dates.
  • Strong communication, collaboration skills and ability to drive accountability.
  • Strong problem-solving skillset.

  • Preferred Experience And Skills

    • Vaccine manufacturing
    • Sterile processing
    • Technical writing (e.g. investigations, technical protocols/reports)
    • Investigative tools (e.g. 5-whys, fishbone)
    • Experience authoring investigations for atypical events in a manufacturing environment

    Responsibilities

    • Leads and/or works as a team member on deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment.
    • Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
    • Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize, and/or gain efficiencies.
    • Manages timelines to ensure key compliance and customer due dates are met; escalates any potential misses and develops remediation plans when possible.
    • Assures consistent application of standardized work, engineering, and process tools.
    • Provides technical support to manufacturing shop floor for problems and issues.
    • Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
    • Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.