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.
Requirements
- Follow all safety procedures, including the proper use of PPE.
- 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.
- 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.
Benefits
- Paid time off
- Life insurance
- Health insurance