Job Summary: |
Responsible for the accurate and efficient assembly, packaging, and labeling of medical products in compliance with GMP requirements, Client procedures, and quality standards. This role supports manufacturing operations by performing assembly processes and operating equipment, ensuring product quality, maintaining a safe work environment, and communicating any production issues. |
Job Responsibilities: (Primary Duties, Roles, and/or Authorities) |
Perform assembly, packaging, and labeling of medical devices and pharmaceutical products (e.g., Surgical, Vascular) in accordance with GMP, SOPs, and quality standards.
Accurately complete and maintain all required documentation, including batch records, production logs, and reports, ensuring compliance with GMP, GDP, FDA, and ISO standards.
Monitor, capture, and report downtime, scrap, and production performance metrics.
Follow all safety requirements and properly use personal protective equipment (PPE), including but not limited to lab coats, gloves, hair/beard covers, shoe covers, hearing protection, eye protection, and specialized cleanroom garments as required.
Communicate production issues, risks, deviations, or safety concerns to the supervisor or designee in a timely manner.
Support continuous improvement initiatives, including 5S, standardization, and process simplification.
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Education and Experience: |
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Knowledge and Skills: |
Ability to perform inspections and testing activities (e.g., visual, in-process, and final inspections).
Complies with required gowning and personal protective equipment (PPE) requirements, including ear plugs, hair net, head cover, mask, safety glasses, lab coat, gloves, dedicated shoes, shoe covers, and any other applicable protective equipment.
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Physical Demands: (if applicable) |
Cleanroom or controlled manufacturing setting required protective gear. |
Work Environment: (if applicable) |
Manufacturing. |