Bausch Health

  • Senior Quality Engineer

    Job Location US-FL-Tampa
    Job ID
    11121
    Pos. Category
    Quality
    Pos. Type
    Full Time
  • Overview

    The Senior Quality Engineer will support manufacturing quality assurance in the manufacturing, packaging, product release, and related systems. The position supports new quality system/methodologies implementation, training, and problem solving, including leading non-conformance investigations, root cause analysis, and development of corrective and preventive actions.

     

    This position will work directly with Manufacturing, Engineering, Quality Control, and other Senior Quality Engineers to provide sustaining quality and compliance leadership.  It is responsible for trending key quality metrics to drive quality, continuous improvement, and efficiency.

    Responsibilities

    • Oversee and direct implementation of CAPA, and NC systems.
    • Monitor content quality of quality system records and work with owners to address issues. Where appropriate, lead or participate in investigation teams. 
    • Monitor and report on timely completion of quality system records.
    • Lead continuous improvement activities for the site quality systems.
    • As assigned, represent the Quality Manager on project teams and implementation of continuous improvement efforts within the department and across the site.
    • Review and approve records ensuring compliance to site procedures and cGMP.
    • Manage the material status process for electronic and physical holding and release from holding. Evaluate and provide decisions on material suitability for further processing.
    • Assist functional areas with systematic problem-solving methodologies when resolving quality issues.

    Qualifications

    BS in Engineering, Chemistry, Biology, or related field. A combination of education and experience will be considered.

     

    Special Skills: Quality Engineering training in statistics, validation, and working knowledge of compounding, filling (aseptic / non-sterile) and packaging processes within the pharmaceutical industry.

    Ability to work independently. Ability to communicate and work well with others. Knowledge of sampling plans (e.g. Mil standard) and GxP compliance requirements. Six Sigma training and ASQ certification preferred.

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