Production Associate (GMP Associate I)

Location: Clinton, PA 15026

Duration: 9-month contract-to-hire

Shifts Available:

1st Shift: 6:00 AM - 2:00 PM

2nd Shift: 2:00 PM - 10:00 PM

3rd Shift: 10:00 PM - 6:00 AM

Job Summary

The GMP Associate I helps produce high-quality medical devices. This includes operating equipment, packing products, loading materials, and fixing basic machine issues using HMI (Human-Machine Interface) screens. The role requires following strict safety, quality, and cleanroom standards while working as part of a team.

Key Responsibilities

Safety

Follow all safety rules and wear required protective equipment (PPE).

Report any hazards, equipment issues, or incidents immediately.

Quality

Follow cleanroom procedures and proper gowning requirements.

Keep accurate and compliant records (batch records, logs, documentation).

Perform routine quality checks during production.

Follow GMP, FDA, and ISO 13485 standards.

Manufacturing & Production

Load materials into machines and monitor supply levels.

Assemble products according to instructions.

Package finished products and complete required documentation.

Operate machinery and fix basic issues using HMI systems; escalate when needed.

Clean and sanitize equipment and work areas regularly.

Continuous Improvement

Participate in improvement activities such as 5S and Kaizen.

Complete required training related to lean manufacturing practices.

Teamwork & Company Values

Work with teams such as Quality and Engineering to meet production goals.

Follow company policies and maintain a professional attitude.

Qualifications

High school diploma or equivalent required.

Manufacturing or production experience preferred.

Basic knowledge of HMI systems and cleanroom environments is a plus.

Strong attention to detail and commitment to quality.

Ability to stand for long periods and perform repetitive tasks.

Willingness to wear full cleanroom protective gear.

Physical Requirements

Stand for extended periods.

Perform repetitive tasks.

Lift or move up to 25 lbs.

Wear cleanroom attire (gown, mask, gloves) for long periods.

Fusion Life Sciences Technologies LLC jobs

good manufacturing practice / cleanroom cleaner