Operator 1, Other Production

Responsible for the accurate and efficient assembly, packaging, and labeling of medical products in compliance with GMP requirements, the client's 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.

Education and Experience:

• High School Diploma/GED

Knowledge and Skills:

• Works safely and follows established safety procedures.
• Basic understanding of manufacturing processes and production flow.
• Ability to follow standard work instructions, SOPs, and product specifications.
• Ability to perform inspections and testing activities (e.g., visual, in-process, and final inspections).
• Good verbal and written communication skills; Spanish/English bilingual preferred.
• Completes required documentation accurately, neatly, and legibly.
• Ability to maintain organization and cleanliness in assigned work areas.
• Works as part of a team to meet operational goals.
• 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.

Physical Demands: (if applicable)

• Cleanroom or controlled manufacturing setting required protective gear.

Work Environment: (if applicable)

• Manufacturing.
• Perform assembly, packaging, and labeling of medical devices and pharmaceutical products (e.g., Surgical, Vascular) in accordance with GMP, SOPs, and quality standards.
• Operate manufacturing equipment and execute assigned processes following standard work instructions, batch records, and product specifications.
• Interpret manufacturing documentation to ensure proper process execution.
• Perform in-process and final visual inspections to ensure product and packaging meet quality requirements.
• Accurately complete and maintain all required documentation, including batch records, production logs, and reports, ensuring compliance with GMP, GDP, FDA, and ISO standards.
• Review batch records for completeness and accuracy prior to submission.
• Meet daily production targets according to the day-by-hour production plan.
• Monitor, capture, and report downtime, scrap, and production performance metrics.
• Ensure availability of required materials prior to initiating operations.
• Handle, segregate, and dispose of non-conforming materials according to established procedures.
• Maintain a clean and organized work area in accordance with 5S and cleanroom standards, including performing routine cleaning of equipment and workstations.
• 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 manufacturing-related activities such as calibration, work orders, and validation activities as required.
• Assist in training new associates and support knowledge transfer within the team.
• Support continuous improvement initiatives, including 5S, standardization, and process simplification.
• Provide support as backup in other operations, equipment, or areas as needed.
• Comply with all company policies and regulatory requirements.
• Perform other duties as assigned.