General Assembler

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.

• 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.

Education:

• High School Diploma/GED.

Experience:

• 4 months of work experience in a manufacturing environment preferred.

• Knowledge of EH&S standards and safety procedures.
• Basic understanding of manufacturing processes and production flow.
• Knowledge of GMP and Quality Systems; familiarity with GDP is preferred.
• 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).
• Basic troubleshooting and problem-solving skills related to equipment and processes.
• Basic mathematical skills (addition, subtraction, multiplication, division, fractions, decimals, and percentages).
• Basic computer skills, including proficiency in a Windows environment and Microsoft Office (Outlook, Word, Excel).
• Effective oral and written communication skills; bilingual Spanish/English preferred.
• Ability to work in a team environment and follow direction.
• Self-motivated and able to work with minimal supervision.
• Operational & Continuous Improvement
  
  Skills:
• Understanding of 5S and Lean workplace principles.
• Ability to maintain organization and cleanliness in assigned work areas.
• Awareness of production metrics and performance expectations.

• Cleanroom or controlled manufacturing setting required protective gear.

• Manufacturing.