Assembler I

Position Summary: The Assembler I works under general supervision to perform assembly, filling, packaging, and preparation activities in a manufacturing environment. This position requires a high level of attention to detail, the ability to follow written work instructions, and accurate completion of production documentation. The individual will set up and operate Masterflex equipment to dispense specified volumes and will use established guidelines and work orders to complete assigned tasks. The role involves extensive paperwork, basic GMP knowledge, routine equipment adjustments, and support of quality and continuous improvement activities. This position requires standing for the majority of the workday and rotating between tasks. The employee may lift up to 15 pounds.

Key Responsibilities: Set up and perform assembly, filling, packaging, and preparation operations in accordance with approved procedures, work orders, GMP requirements, and quality system standards. Set up and operate Masterflex equipment to dispense required volumes according to established guidelines. Perform line clearance, equipment setup, routine adjustments, housekeeping, and preventative maintenance activities. Assemble, inspect, test, and package products by following detailed written or verbal instructions. Complete production, equipment, maintenance, and quality documentation accurately and on time. Perform routine equipment cleaning, maintenance, minor repairs, and documentation of completed activities. Assist Engineering and Maintenance teams with equipment troubleshooting, maintenance, and repairs. Identify and report product or equipment issues and assist with problem-solving activities. Participate in root-cause analysis and corrective actions under the direction of a Supervisor or Manager. Support continuous improvement initiatives, including 5S and Overall Equipment Effectiveness (OEE) activities. Assist with new equipment installation and validation activities as needed. Dispose of hazardous waste materials in designated hazardous-waste areas in accordance with company procedures. Collaborate with Engineering, Maintenance, Quality Control, and Management to identify and implement process improvements. Maintain a clean, organized, and safe work area. Demonstrate professional and customer-focused behavior when working with internal and external business all duties in compliance with established company policies, procedures, and quality standards. Perform other duties as assigned based on changing business needs.

Required Qualifications: High school diploma or GED.Two to five years of experience in assembly, filling, packaging, reagent handling, or a related manufacturing environment. Experience reading and following work orders, standard operating procedures, or detailed work instructions. Basic understanding of GMP principles and manufacturing math skills, including the ability to measure and verify volumes. Basic computer skills and minimal Microsoft Excel experience. Basic verbal and written communication skills. Ability to complete handwritten and printed documentation to perform routine troubleshooting using established procedures. Ability to stand for extended periods and rotate between tasks throughout the workday. Ability to lift up to 15 pounds. Ability to work effectively in a quality-system environment.

Preferred Qualifications: Approximately three years of experience in medical device, pharmaceutical, biotechnology, or other regulated manufacturing. Experience with filling and packaging reagents. Experience operating or setting up Masterflex equipment. Experience in a pharmaceutical or medical device manufacturing environment. Food manufacturing or other highly controlled production experience may be considered. Experience with Microsoft Office with FDA, ISO, OSHA, or other applicable understanding of manufacturing systems, including documentation, compliance, inventory control, production scheduling, and production controls.