GMP Associate

Title: GMP Associate

Location: Clinton, PA, 15026

Duration: 6 Months

Shift: 6:30 PM - 6:45 AM (2-2-3)

Summary:

The GMP Associate I supports the manufacturing of high-quality medical devices by operating equipment, packing finished products, loading automatic hoppers, and resolving basic equipment faults through HMI (Human-Machine Interface) screens. This role requires adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and cleanroom standards while contributing to a safe, lean, and team-oriented environment.

Key Responsibilities

1. Safety
• Follow all safety procedures, including the proper use of PPE.
• Report hazards, malfunctions, and incidents promptly.

2. Quality
• Adhere to cleanroom protocols and gowning requirements.
• Maintain accurate, compliant documentation (batch records, logs, GDP).
• Perform in-process checks and follow GMP, FDA, and ISO 13485 standards.

3. Manufacturing & Delivery
• Load hoppers and monitor material levels to avoid interruptions.
• Assemble components and subassemblies per work instructions.
• Execute activities in molding such as proper packaging and completion of GDP paperwork.
• Operate production equipment and resolve basic HMI faults, escalating as needed.
• Perform routine cleaning and sanitization of equipment and workspace.

4. Continuous Improvement
• Participate in lean initiatives (5S, Kaizen, QEK).
• Complete required lean curriculum for associate level.

5. Company Values
• Collaborate with Quality, Engineering, and other teams to achieve production goals.
• Uphold company values and policies with professionalism.
• Stand for extended periods; perform repetitive tasks.
• Lift/move up to 25 lbs as needed.
• Wear cleanroom attire (gown, mask, gloves) for prolonged periods.

Physical Requirements
• Stand for extended periods; perform repetitive motions.
• Lift/move up to 25 lbs as needed.
• Wear cleanroom attire (gown, mask, gloves) for prolonged periods.