Label Control Quality Tech II

GUERBETRaleigh, NC
69d

About The Position

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients. Customer centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

Requirements

  • Associates degree or equivalent pharmaceutical experience (3-5 years).
  • Strong understanding of cGMP regulations, FDA/USP requirements, and pharmaceutical labeling compliance standards.
  • Excellent attention to detail with strong documentation and organizational skills.
  • Ability to lead and train peers in labeling procedures and quality best practices.
  • Proficient in Microsoft Office Suite (Word, Excel, Outlook).
  • Strong written and verbal communication skills to support investigations, audit responses, and cross-functional coordination.

Nice To Haves

  • Technical proficiency in SAP (or other ERP systems).

Responsibilities

  • Inspection of all incoming label materials according to SOPs and set standards.
  • Approving compliant label materials per SOPs and/or Reject label materials not meeting set standards per SOPs, as applicable.
  • Issuing label materials to production, assuring 100% accuracy to prevent labeling related product recalls.
  • Confirming reconciliation has been performed in ERP by production.
  • Completing physical and ERP label material returns to inventory, as applicable.
  • Maintaining accurate label inventory and proper storage.
  • Documenting all label control activities in compliance with Good Documentation Practice.
  • Collaborating with M&D, Planning, and Packaging teams to ensure timely label availability. Communicating all concerns to applicable teams.
  • Supporting audits and investigations related to labeling discrepancies.
  • Assisting in training new team members and updating SOPs, as needed.
  • Coordinating label room activities to meet production and packaging schedules without compromising quality or compliance.
  • Working safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.
  • Performing other duties as assigned by management.
  • Ensuring printers and dept. machinery remain in a calibrated state.
  • Partnering with Quality Systems to support audits, inspection readiness, and CAPA implementation related to labeling activities.
  • Supporting periodic inventory counts and reconciliation of printed label materials with Supply Chain and Warehouse teams.
  • Participating in periodic review and revision of SOPs, work instructions, and label control procedures.
  • Assisting with the preparation of quality metrics and department KPIs related to labeling performance.

Benefits

  • Continued personal development.
  • Joining a global leader with recognized expertise in diagnostic and interventional imaging.
  • Being part of a diverse team committed to improving quality of patient's life.

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What This Job Offers

Industry

Computer and Electronic Product Manufacturing

Education Level

Associate degree

Number of Employees

1,001-5,000 employees

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