Lead Label Control Specialist

GENERAL PURPOSE

The Lead Label Control Specialist is responsible for supporting and coordinating day-to-day label control operations across Eagle Labs sites. This role functions as a working lead, providing guidance, direction, and process oversight to Label Control personnel while ensuring compliance with 21 CFR Part 111 and other applicable regulatory standards.

Under the guidance of the Senior Label and Printing Manager, and the Label Control Specialist Supervisor; the Lead will support training, process adherence, documentation, and cross-functional coordination. This role is responsible for driving consistency in labeling processes, ensuring tasks are completed and properly closed out, and supporting the team in meeting production timelines.

This position requires strong leadership presence, accountability, and the ability to reinforce established processes.

POSITION RESPONSIBILITIES 

• Coordinate and support daily labeling activities across multiple sites, ensuring consistency in execution and adherence to established processes.
• Serve as a point of contact for Label Control team members, providing guidance on task prioritization, process steps, and issue resolution.
• Reinforce adherence to SOPs, work instructions, and system requirements (e.g., Batch Master, WMS), ensuring tasks are completed accurately and fully closed out.
• Monitor labeling workflows to ensure proper handoffs, timely progression of work, and completion of required documentation and system updates.
• Train and support Label Control personnel on processes, systems, documentation requirements, and regulatory expectations.
• Maintain working knowledge of cGMPs, FDA regulations, and 21 CFR Part 111 (Subparts G and P), applying this knowledge to daily operations.
• Support development, maintenance, and continuous improvement of SOPs, work instructions, and process documentation.
• Audit and verify label content (proofs/art files) against approved specifications and ensure alignment with final approved documentation.
• Assist with investigations, deviations, and CAPAs, providing documentation support and ensuring follow-through on assigned actions.
• Monitor and support inventory control of printed packaging components, including reconciliation between physical inventory and system records.
• Track, organize, and communicate the status of labeling projects to internal stakeholders to support production timelines.
• Notify appropriate teams of labeling changes and ensure implementation timelines are clearly communicated and followed.
• Identify gaps in process adherence and work with leadership to implement corrective actions and improvements.
• Support cross-functional coordination with Operations, Quality, Purchasing, and external vendors to ensure alignment and timely execution.
• Participate as a subject matter expert (SME) during internal, client, and regulatory audits or inspections, as needed.
• Work beyond the standard 40-hour workweek as needed, including evenings or weekends, based on business needs.

MINIMUM QUALIFICATIONS

Education

Experience

Minimum 3 Years’ experience in a cGMP Environment. Minimum 3 years’ experience in Quality Assurance

or production preferably in the nutraceutical, pharmaceutical or cosmetic industry.

1 years’ experience in a leadership role in the nutraceutical, pharmaceutical, or cosmetic industry, preferably Quality Assurance/Control.

Knowledge, Skills, and Abilities