Quality Specialist - Weston, United States - Stefanini

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    Description

    Stefanini Group is hiring

    Stefanini is looking for Quality Specialist in Weston, FL (Hybrid)

    For quick Apply, please reach out to Nitin Kumar Chandila - call:

    / email:

    Work Hours: M-F (40 hours)

    Work Location: Weston, FL

    Shift: 1st Shift (9:00 AM - 6:00 PM) (3 days in office and 2 days remote) Hybrid

  • The Drug Supply Chain Security Act (DSCSA) was signed into law on November 27, 2013, intending to promote greater safety of RX products.
  • The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs for distribution through the supply chain. Full track and trace will be achieved by:
  • Facilitating the electronic exchange of transaction information for each sale of prescription drugs.
  • Use and review product identifiers to verify products at the item level.
  • Improve the efficiency of recalls.
  • Support the development, implementation, and ongoing management of Drug Supply Chain Security Act (DSCSA) to maintain Compliance.
  • In this role, you will learn the interoperable system to set up and establish connections between Anda and its Trading Partners related to this exciting and trailblazing program.
  • Responsibility:

  • Acquire in-depth knowledge of the TraceLink system and sub-modules (training will be provided).
  • Collaborate with various levels of management, cross-functional teams, and external stakeholders.
  • Highly organized with the ability to manage, track and escalate (as needed) multiple tasks and activities.
  • Conduct testing with vendors, customers and serialization providers to ensure successful connectivity.
  • Excellent written and oral communication skills is a must; individual will be working directly with Anda customers and vendors via email or phone to coordinate the onboarding into the TraceLink application.
  • Support end users with issues related to the TraceLink application, EPCIS file errors, and sub-modules.
  • Perform all activities in compliance with the internal and external requirements/standards controls.
  • Perform activities such as computer work, preparing, investigating, researching, and analyzing data.
  • Perform related duties as assigned and may cross-train to support other Compliance activities.