Production Lead

Production Lead

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.

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.
• 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.

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