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Job Details
Job 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
Safety
- Follow all safety procedures, including the proper use of PPE.
- Report hazards, malfunctions, and incidents promptly.
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.
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.
Continuous Improvement
- Participate in lean initiatives (5S, Kaizen, QEK).
- Complete required lean curriculum for associate level.
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.
Qualifications
- High school diploma or equivalent.
- Prior manufacturing or production experience preferred.
- Basic knowledge of HMI systems and cleanroom procedures 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 PPE.
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.
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