Quality Assurance Specialist

Waukegan, IL

Post Date: 08/02/2017 Job ID: 23006 Category: Information Technology / IT

Job Description:
  • Assures the quality of manufactured products and processes per standard operating processes (SOP'S) and GMP (Good Manufacturing Practices).

  • Review new regulations and assess for impact on the business.
  • Identify documents requiring an update to ensure compliance.
  • Propose updates and obtain agreement on the recommended changes.
  • Review new and updated Quality Agreements for impact.
  • Highlight the issues and concerns and work with the other QA area managers to assess the potential impact.
  • Work with team to redesign the Quality Agreements for all areas, including API and drug product manufacturing internally and at a Third Party Manufacturer, Finishing, Analytical testing, device development.
  • Update other monthly metric review slides as requested.
  • Conduct trials (facilitate) for new processes as requested.
  • Assemble packages of manufacturing and regulatory items for Project Managers to conduct country approval as requested.

Experience & Education:
  • A minimum of 4+ years experience in Quality Assurance or related field.
  • Preferred healthcare industry and specific experience in quality function.
  • Strong understanding of US and international regulations for quality systems and compliance.
  • Effective use of oral and written communication skills to clearly communicate the actions necessary to resolve issues.
  • Bachelor s degree or equivalent experience is required; typically in life sciences or engineering.
  • BS degree or 3-7 years equivalent experience.

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