Production Lead

Aptyx; Taunton (MA); On-site; USD 65,000 - 95,000; Full time

Job summary

Aptyx in Taunton, MA is seeking a Production Lead to oversee daily packaging and labeling in a regulated environment. You will lead a packaging team, ensure GMP/cGMP, GDP, SOP compliance, and support process improvements such as Value Stream Mapping.

The role emphasizes hands-on leadership, quality inspections, labeling control, and training staff to uphold audit readiness, manufacturing cleanliness, and accurate documentation across batches.

Qualifications

• 3-5+ years in packaging/labeling/manufacturing in a GMP-regulated industry.
• 1-3+ years supervisory or lead experience.
• Direct experience with batch records, label reconciliation, GDP/GMP compliance, and final product inspections.

Responsibilities

• Inspect packaged products and verify labels and batch records for accuracy and compliance.
• Manage labeling operations, create/print labels, reconcile labels, and develop templates.
• Provide GDP and packaging training; coach and refresh staff.
• Assist in generating Packing Lists and Bills of Lading for shipments.
• Support raw material receiving and staging, verify against specs.
• Oversee tooling control: inventory, calibration, issuance.
• Lead Value Stream Mapping to reduce waste and improve flow.
• Ensure cleanroom and housekeeping; ensure SOP adherence and audit readiness.
• Perform other duties to support goals.

Skills

cGMP knowledge

GDP knowledge

FDA regulations

SOPs

Documentation

Microsoft Office

Labeling software

Value Stream Mapping

Attention to detail

Leadership

Training staff

Education

High school diploma or GED

Associate's or Bachelor's degree in science/engineering/manufacturing or related field

Job description

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.

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