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Quality Engineer

Company: ObjectWin Technology Inc
Location: Allentown
Posted on: November 10, 2018

Job Description:

Job Description:Job Title : Quality Engineer Duration : 12+ Months ContractLocation : Allentown, Pennsylvania 18106Responsibilities:

  • Apply Good manufacturing Principles in all areas of responsibility.
  • Demonstrate and promotes the company vision.
  • Maintaining current equipment and facilities qualification documentation.
  • Perform impact analysis of changes to facilities and equipment.
  • Review and Approve equipment and facilities qualification documents to ensure compliance with all applicable internal and regulatory standards.
  • Informs management of issues identified during qualification activities and recommends appropriate actions to address the issue(s).
  • Drives continuous improvement to the site's equipment and facilities qualification/validation program.
  • Assist in the authoring of site procedures related to equipment and facilities as required
  • Monitor the site's calibration program.
  • Monitor the site's preventative maintenance program.
  • Author qualification documents as required.
  • Conduct all activities in a safe and efficient manner.
  • Other duties may be assigned to meet business/compliance needs.Minimum Qualifications:
    • Bachelor's Degree.
    • A minimum of 5 years in the pharmaceutical/related regulated industry.
    • Experience with equipment and facilities validation Quality Systems.
    • Experience facilitating FMEAs and risk assessments.
    • Experience in reviewing temperature, humidity, and differential pressure data from internal computer systems.
    • Must be detail oriented to detect errors or deficiencies with equipment and facilities qualification documentation.
    • Possess the ability to use sound judgment in discerning if equipment and facilities qualification documentation accurately and completely reflects the documentation and requirements of the system.
    • Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance.Preferred Qualifications:
      • Good written and verbal communication skills.
      • Thorough understanding of regulatory documentation requirements.
      • Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
      • Ability to work independently.
      • Experience in Microsoft Word, Excel, and Power Point.
      • Experience in Trackwise and Maximo. - provided by Dice Quality Engineer, Manufacturing, GMP, cGMP, pharma, trackwise, Maximo, validation

        Keywords: ObjectWin Technology Inc, Allentown , Quality Engineer, Engineering , Allentown, Pennsylvania

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