GMP Associate

Fusion Life Sciences technologies LLC; Pennsylvania; On-site; USD 25,000 - 33,000; Full time

Job summary

Fusion Life Sciences technologies LLC is seeking a GMP Associate in Clinton, PA to support the production of medical devices. The role involves operating equipment, packing finished products, loading hoppers, and ensuring compliance with GMP, GDP and cleanroom standards.

You'll follow strict safety procedures, maintain accurate documentation, and participate in lean initiatives. The position requires standing for long periods and lifting up to 25 lbs, with a 2-2-3 shift pattern (6:30 PM–6:45 AM).

Responsibilities

• Follow safety procedures, including proper use of PPE.
• Adhere to cleanroom protocols and gowning requirements; maintain GDP documentation.
• Load hoppers, assemble components, and package GDP paperwork; operate production equipment and address basic HMI faults.
• Participate in lean initiatives (5S, Kaizen, QEK) and complete required lean curriculum for associate level.
• Collaborate with Quality, Engineering and other teams to achieve production goals and uphold company values.

Job description

Title:GMPAssociate

Location: Clinton, PA, 15026

Duration: 6 Months

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

Summary

TheGMPAssociate 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 toGood ManufacturingPractices (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 followGMP, 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.