Label Control Quality Tech II (Raleigh, US) na Guerbet

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. 

WHAT WE ARE LOOKING FOR

We are looking for a Label Control Quality Tech that can bring the experience of ensuring accuracy, compliance, and proper handling of labeling materials. This role is critical to ensure that all label materials meet set standards, accuracy of labels issued to production, and accuracy of label inventory.

YOUR ROLE

• 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.

YOUR BACKGROUND

Required:

• 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.

Preferred:

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

Physical Requirements:

• Ability to sit, stand, and walk for extended periods of time throughout the shift.
• Frequent movement between warehouse, label control room, and production/packaging areas.
• Ability to lift, carry, push, or pull up to 40 pounds.
• Frequent use of hands and fingers for typing, handling labels, operating printers, and reviewing documentation.
• Visual acuity required for detailed inspection of printed materials.
• Frequent bending, reaching, and stooping when accessing shelves, drawers, or label bins.
• Ability to wear appropriate Personal Protective Equipment (PPE).
• May be exposed to standard manufacturing noise.

Cognitive Requirements:

• Attention to detail, ability to detect discrepancies in labels, documentation, and ERP system. High level of accuracy in reviewing and verifying information.
• Critical thinking and problem solving, ability to identify labeling issues and determine root causes. Ability to assess risk, escalate issues, and make sound quality decisions.
• High level of focus to identify labeling discrepancies or compliance risks.
• Ability to manage multiple priorities while maintaining compliance with tight timelines.

WHY JOIN US 

We offer continued personal development. When you join Guerbet, you: 

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,  

• Are joining our 3000 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world, 
• Are joining a company where we value diversity of talents coming from various horizons. 

Do you want to help improve patients’ lives with us? 
We look forward to meeting you and continuing our story together! 

We # Innovate # Cooperate # Care #Achieve at Guerbet.  

Guerbet is a signatory of the Diversity Charter. 
We believe diversity is a source of strength, and all our positions are open to everyone. 

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.    

Applicants may be entitled to reasonable accommodation due to disability, pregnancy or related medical condition, or a sincerely held religious belief. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing an undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.    

Guerbet will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.