Position Summary:

The Packaging Lead is responsible for overseeing day-to-day operations within assigned GMP production rooms, ensuring compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and client-specific protocols. This role acts as the key point of contact for room personnel and coordinates activities to meet production schedules for clinical labeling, packaging, and distribution services.

Key Responsibilities:

Lead, coordinate, and monitor all activities within the assigned room during production operations (labeling, packaging, kitting, etc.). Ensure all processes comply with GMP regulations, company SOPs, safety protocols, and client-specific instructions. Conduct room readiness checks and line clearance before initiating work. Review batch records and associated documentation for accuracy and completeness. Train and guide production staff on job-specific tasks and GMP best practices. Act as the first point of escalation for production issues or deviations; report to management as needed. Maintain accurate records of production activities, equipment logs, and cleaning documentation. Collaborate with Quality Assurance during batch reconciliation, deviations, and in-process checks. Support continuous improvement initiatives and maintain a clean, safe, and organized work environment. Participate in audits and regulatory inspections, providing documentation and operational support.

Qualifications:

High school diploma or equivalent required; associate or bachelor's degree preferred. Minimum 2 years of experience in a GMP-regulated manufacturing or clinical supply environment. Prior experience in a lead or supervisory role preferred. Strong understanding of GMP, GDP, and applicable regulatory requirements (FDA, EMA). Excellent communication, leadership, and organizational skills. Detail-oriented with a focus on accuracy and compliance. Proficient in MS Office and experience with ERP or MES systems is a plus.

Physical Requirements:

Ability to stand for extended periods and perform manual tasks (e.g., handling supplies, packaging). Must be able to lift up to 30 lbs occasionally. Use of PPE and cleanroom garments as required.

Job Type:

Full-time Language:

English (Required) Ability to

Commute:

Allentown, PA 18106 (Required) Ability to

Relocate:

Allentown, PA 18106: Relocate before starting work (Preferred)

Work Location:

In person