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GMP Associate
Job in
Philadelphia, Philadelphia County, Pennsylvania, 19117, USA
Listed on 2026-10-03
Listing for:
Fusion Life Sciences technologies LLC
Full Time
position Listed on 2026-10-03
Job specializations:
-
Manufacturing / Production
Manufacturing & Industrial Operations, Production Associate / Production Line, Assembly, Production QC/QA
Job Description & How to Apply Below
Title:GMPAssociate
Location
:
Clinton, PA, 15026
Duration: 6 Months
Shift:6:30 PM - 6:45 AM (2-2-3)
SummaryTheGMPAssociate 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 Manufacturing Practices (GMP), Good Documentation Practices (GDP), and cleanroom standards while contributing to a safe, lean, and team-oriented environment.
Key Responsibilities1. Safety
- Follow all safety procedures, including the proper use of PPE.
- Report hazards, malfunctions, and incidents promptly.
- 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.
- 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.
- Participate in lean initiatives (5S, Kaizen, QEK).
- Complete required lean curriculum for associate level.
- 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.
- Stand for extended periods; perform repetitive motions.
- Lift/move up to 25 lbs as needed.
- Wear cleanroom attire (gown, mask, gloves) for prolonged periods.
Position Requirements
10+ Years
work experience
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