Packaging Room Lead

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