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Guerbet · 19 hours ago

Label Control Quality Tech

Raleigh, NC

Full-time

Onsite

Mid Level

3+ years exp

Guerbet is seeking a Label Control Quality Tech to ensure accuracy, compliance, and proper handling of labeling materials. This role is critical for maintaining label standards and inventory, while collaborating with various teams to support production and audits.

Health CareMedicalPharmaceutical

Hiring Manager

Kris Adams

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. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately

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 (e.g., error rates, on-time issuance, reconciliation timelines)

Performing other duties as assigned by management

Qualification

CGMP regulationsFDA/USP requirementsLabeling compliance standardsMicrosoft Office SuiteSAP proficiencyAttention to detailDocumentation skillsOrganizational skillsCommunication skillsCritical thinkingProblem solving