Manufacturing Technician I - Temp

Genalyte • San Diego, CA

10d • $21 - $24 • Onsite

About The Position

Genalyte is a San Diego-based diagnostics company developing the Merlin platform, a novel photonic ring resonator-based system designed to deliver rapid, multiplexed diagnostic results. We believe that timely and accurate health insights shouldn’t be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.

Requirements

• High School education or completion of GED with a minimum of 3 years experience in an FDA regulated environment with basic laboratory operations principles such as PPE, handling of refrigerated or frozen biological materials, handling chemically and/or biologically hazardous materials and basic laboratory equipment (an equivalent combination of experience and education may be considered)
• Proficient in general hand and small tools, such as tweezers
• Demonstrated good hand-eye coordination
• Ability to apply common sense understanding to carry out detailed but involved written or oral instructions
• Proficient computer skills and good working knowledge of Microsoft Office and Google Suite programs
• Ability to perform basic math and calculations using weight measurement, volume, and distance governed by Quality documents and Standard Operating Procedures
• Ability to demonstrate exceptional attention to detail
• Good oral communication skills and proficiency in English (verbal and written)

Nice To Haves

• Prior experience in medical devices, diagnostics (IVD), or healthcare technology in a regulated environment is preferred
• Experience working with biological testing is a plus
• Previous experience with pipetting and filling of well-plate preferred

Responsibilities

• Perform all duties that are required to produce reagents, intermediate consumables and finished good kits.
• Manual manipulation of small components in the assembly of consumables items
• Manual and semi-automated liquid filling and QC verification of reagents into consumables
• Manual and semi-automated finished goods kitting
• Reagent formulation and use in the production environment including exposure to aqueous and organic hazardous materials such as acetone and isopropanol
• Material management which consists of timely transfer and replenishment of materials and/or supplies to point-of-use location
• Ensure inventory accuracy
• Perform precision hand placement of small components
• Notify area leadership or engineering of product discrepancies
• Maintain or exceed acceptable productivity levels while maintaining a consistent and acceptable level of quality
• Maintain a high level of cooperation and positive interaction with team members and peers
• Accurately complete all documentation associated with manufacturing processes
• Maintain compliance with all company policies, quality systems, and procedures
• Train to cGMP, ISO 13485 and 21 CFR part 820 requirements and perform activities in compliance with them
• Able to perform all tasks above following written procedures (including assembly drawings), filling out batch records and tracking intermediate and finished goods inventory for each task.
• Employ cleaning procedures, aseptic processing techniques, current Good Manufacturing Practices (cGMP), in a clean room with chemical and biological safety practices including exposure to dry environments and hazardous materials
• Perform other duties as assigned by area leadership

Benefits

• The base salary range for this role is $21 - $24 per hour. Individual pay may vary based on job-related skills, experience, and relevant education or training.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED