Quality Specialist

6 days ago


Omaha, United States Merck Full time

12-month assignment through AgileOne

  • Health benefits offered


Requirements:

  • Highschool diploma with 3+ years of related experience OR associates degree with 1+ years of related experience
  • Quality experience in a regulated industry
  • Strong communication skills
  • Experience with investigations, risk assessments, and regulatory inspections.
  • Skilled in technical writing
  • Experience with Quality Assurance systems such as Reliance, TrackWise, SAP


Preferred Experience and Skills:

  • Familiarity and/or experience with vaccine manufacturing and specifically packaging
  • Familiarity and/or experience with USDA regulations and inspections, and knowledge regarding the Animal Health Quality Manual
  • Project Management experience


Position Description:

  • This role will primarily support Manufacturing Operations and will serve as the primary QA for the PS&S (Packing Simplification and Sustainability) Initiative
  • Provide guidance to the PS&S team from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, AND CGMP generally.
  • Serve in the quality role in Reliance quality system, Deviation management, and change controls for the packaging initiative.
  • Regularly spend time within the department to learn processes, evaluate compliance and build relationships of trust with production operators and management
  • Assist with day-to-day packaging related quality questions and inquiries
  • Update and review SOP's the relate to the packaging department
  • Occasionally assign short term tasks and projects with varying degrees of urgency and difficulty and thus organization, critical thinking and creativity are necessary attributes for this role
  • A successful candidate will navigate the carious perspectives of planning, QA, and production utilizing leadership behaviors and principals of inclusion, while holding safety and quality as primary values

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