General Assembler 1

Job Summary:
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.
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.
• 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 and Experience:
Education:

• High School Diploma/GED.

Experience:

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

Professional Skills:

• 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.

Physical Demands:

• Cleanroom or controlled manufacturing setting required protective gear.

Work Environment: (if applicable):

• Manufacturing.