Production Lead

Job Summary

The Production Lead is responsible for overseeing daily packaging and labeling operations in a regulated manufacturing environment. This hands‑on leadership role ensures compliance with Good Manufacturing Practices (GMP/cGMP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs), and customer‑specific requirements. The incumbent leads a team of packaging staff, performs quality inspections, manages labeling processes, supports production logistics, maintains manufacturing tooling and cleanliness standards, and contributes to process improvement initiatives such as Value Stream Mapping.

• 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.
• Assist 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.

• 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.

• 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.

• 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.