Label Control Quality Tech

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.