GMP Associate

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. #J-18808-Ljbffr Fusion Life Sciences technologies LLC