Production Lead

Job Summary

Key Responsibilities

• Conduct inspection of packaged products, including verification of labels and batch records for accuracy, completeness, and compliance with regulatory and customer standards.
• Manage all aspects of labeling operations, including creating and printing labels, performing label reconciliation (to prevent mix-ups or shortages), and developing new label templates based on customer requirements.
• Provide GDP and packaging-specific training for staff, ensuring team members are certified and competent in relevant procedures; deliver ongoing coaching and refresher sessions as needed.
• Aid in the generation of Packing Lists and Bills of Lading (BOL) to support accurate shipment documentation and logistics.
• Support raw material incoming processes, including staging of raw materials for production use and verification against specifications.
• Oversee manufacturing tooling control, including inventory, maintenance, calibration tracking, and issuance/retrieval to ensure availability and compliance.
• Lead Value Stream Mapping activities to identify inefficiencies, reduce waste, and improve flow in packaging and related processes.
• Maintain oversight of the manufacturing area and clean space/cleanroom cleanliness; routinely confirm that SOPs are followed, deviations are addressed promptly, and housekeeping standards are met to support audit readiness.
• Perform other duties as assigned to support production goals, quality assurance, and continuous improvement.

Qualifications & Requirements

• Education: High school diploma or GED required; Associate's or Bachelor's degree in a science, engineering, manufacturing, supply chain management, or related field preferred.
• Experience: 3-5+ years of hands-on experience in packaging, labeling, or manufacturing operations within a GMP-regulated industry (pharmaceutical, medical device, biotech, dietary supplements, or similar); 1-3+ years of supervisory or lead experience, including training staff and overseeing teams; direct experience with batch records, label reconciliation, GDP/GMP compliance, and final product inspections.
• Skills & Knowledge: Strong working knowledge of cGMP, GDP, FDA regulations, SOPs, and documentation requirements; proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Outlook) for record-keeping, reporting, and template creation; familiarity with labeling software/systems and value stream mapping/lean principles is a plus; excellent attention to detail, organizational skills, and ability to manage multiple priorities in a fast-paced environment; effective communication and leadership skills to train, motivate, and guide team members.

Salary

$58000.00 - $63000.00 per year