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Quality Assurance Associate

Company: Medicago
Location: Durham
Posted on: June 26, 2022

Job Description:

Medicago: A history of innovation and perseveranceWe started our journey with one objective: to help protect human life and today, we are a global leader in developing and producing plant-based vaccines and therapeutics.
Your role:The incumbent is responsible for small, short-term projects and sub projects of larger projects. Project goals, success markers and determine how success measurement will be defined. The incumbent supports the organization as defined via support in raw material release, QA on the floor, and/or master control integration/support.
What your days would look like:

  • Executes one or more of the following with minimal supervision: raw material release, QA on the floor, batch record review, eQMS support/SME designated actions, Master Control related projects;
  • Performs QA review of applicable executed quality records in any of the following categories: log books, cleaning logs, technical documents, validation documents;
  • Ensures materials and batches are manufactured in compliance with regulations and site documentation;
  • Supports good documentation practices, data integrity compliance and site inspection readiness;
  • Supports cross-functional teams to maintain system health and escalate barriers as required.
    Required profile:
    • Bachelor's degree in Science or relevant field;
    • 2 to 4 years' experience;
    • ASQ or related certification preferred;
    • GxP terminology, experience and working knowledge in phase appropriate environments ranging from phase 2 to commercial;
    • Basic negotiation and influencing skills;
    • Understanding of risk management principles;
    • Industry CMC, and/or non-clinical and/or clinical and/or analytical knowledge.
      Medicago is changing the game!
      Our Vision: Medicago envisions a world that is prepared to face any disease
      Our Mission: To create and deliver effective responses to new global health challenges.Our mission is driven by the values of innovation, integrity, collaboration, adaptability, and ownership. These values reflect the spirit and culture that inspire Medicago's people.
      As a pioneer in transient expression and plant-based manufacturing, Medicago has always sought a more effective way to improve human health. With nearly 20 years of experience and wisdom behind us, we are poised to revolutionize the traditional approach to vaccines and therapeutics.
      It is important that you are legally entitled to work in the US or Canada at the time the job offer is made to you. You may be asked to provide proof of eligibility.

Keywords: Medicago, Durham , Quality Assurance Associate, Other , Durham, North Carolina

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