Job Summary: 

Responsible for performing assembly, packaging, and labeling of medical products with a higher level of proficiency, in compliance with GMP requirements, BD procedures, and quality standards. This role operates manufacturing equipment across multiple processes, ensures product quality, and supports manufacturing operations by troubleshooting issues, assisting in process execution, and promoting adherence to safety and operational standards. Additionally, this position provides support to other areas and helps reinforce process awareness among associates. 

Demonstrates initiative, willingness, and a positive attitude to continuously develop skills and knowledge within certified operations. Promotes process awareness among associates and contributes to personal and team development through daily performance. 

Job Responsibilities: 

• Perform assembly, packaging, and labeling of medical devices and pharmaceutical products in compliance with GMP, SOPs, and quality standards. 

• Operate and be certified in multiple manufacturing processes or groups of operations across different areas. 

• Execute production activities using batch records, job aids, SOPs, and product specifications. 

• Interpret manufacturing documentation to ensure accurate and efficient process execution. 

• Perform in-process and final visual inspections to ensure product and packaging meet quality requirements. 

• Accurately complete and review batch records, production logs, and documentation in compliance with GMP, GDP, FDA, and ISO standards. 

• Meet daily production targets in alignment with the established day-by-hour production plan. 

• Monitor, capture, and report downtime, scrap, and production performance metrics. 

• Coordinate execution of manufacturing schedules for assigned batches or operations. 

• Ensure availability of required materials before initiating operations. 

• Handle, segregate, and dispose of non-conforming materials in accordance with established procedures. 

• Maintain cleanliness and organization of work areas, equipment, and operations in alignment with 5S and cleanroom standards. 

• Support manufacturing-related activities including calibration, work orders, and validation processes as required. 

• Identify, troubleshoot, and communicate production issues, risks, or deviations to the supervisor or designee in a timely manner. 

• Support and maintain a safe work environment, including participation in safety programs such as Employee Safety Observations (ESO). 

• Follow all safety requirements and properly use pers