General Assembler

Job Title

Job Summary: Responsible for the assembly, packaging, and labelling of medical devices and pharmaceutical products in compliance with GMP requirements, standard operating procedures (SOPs), and quality standards. Ensures product quality through inspections, accurate documentation, safe equipment operation, and maintaining a clean manufacturing environment.

Roles & Responsibilities:

• Perform assembly, packaging, and labelling of medical devices and pharmaceutical products according to GMP, SOPs, and quality standards.
• Operate manufacturing equipment and follow standard work instructions, batch records, and product specifications.
• Perform in-process and final visual inspections to ensure product quality.
• Complete and maintain accurate production documentation, batch records, logs, and reports.
• Review batch records for completeness and accuracy before submission.
• Meet daily production targets and monitor production performance, downtime, and scrap.
• Ensure required materials are available before starting production activities.
• Handle and dispose of non-conforming materials according to established procedures.
• Maintain a clean and organized work area in accordance with 5S and cleanroom standards.
• Follow safety procedures and use required personal protective equipment (PPE) and cleanroom garments.
• Report production issues, process deviations, and safety concerns to supervisors.
• Support equipment calibration, work orders, validation activities, and continuous improvement initiatives.
• Assist in training new associates and provide backup support in other manufacturing areas as needed.
• Comply with company policies and applicable regulatory requirements.

Education & Experience:

• High School Diploma or GED required.
• Ability to follow manufacturing instructions, SOPs, and product specifications.
• Basic understanding of manufacturing processes and production operations.
• Experience in assembly, packaging, labelling, or medical device manufacturing is beneficial.
• Ability to perform visual inspections and maintain accurate production documentation.
• Ability to work in a cleanroom or controlled manufacturing environment and follow PPE requirements.