Manufacturing Technician I - Temp

Genalyte, Inc; San Diego (CA); On-site; USD 29,000 - 33,000; Full time

Job summary

Genalyte, Inc. in San Diego, CA, seeks a Manufacturing support specialist to assemble and package diagnostic kits, prepare reagents, and manage materials in a GMP environment.

You will follow SOPs, document batch records, and ensure quality while contributing to a fast-paced operations team. Ideal candidates have a high school diploma or GED with FDA-regulated experience, basic lab skills, and proficiency with Microsoft Office.

Qualifications

• High School or GED with a minimum of 3 years experience in an FDA-regulated environment with basic lab operations principles (PPE, handling of refrigerated or frozen materials, hazardous materials, basic lab equipment).
• Experience in medical devices/diagnostics in regulated settings preferred.
• Ability to follow written procedures and batch records.

Responsibilities

• Assemble, package, and kit reagents and finished goods in a clean room/GMP environment.
• Perform liquid filling and QC verification of reagents and consumables.
• Maintain inventory accuracy and document manufacturing processes.
• Comply with cGMP, ISO 13485, and 21 CFR part 820 requirements; prepare batch records.

Skills

Hand tools & precision work

Hand-eye coordination

Attention to detail

English communication

Basic math

Computer literacy

Overtime flexibility

Education

High School / GED + 3 years FDA environment

Tools

Tweezers

Pipetting

Job description

ABOUT GENALYTE

At Genalyte, we’re revolutionizing diagnostic testing to empower a healthier future. 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.

POSITION SUMMARY

Under supervision, performs a variety of manufacturing functions including assembly and packaging of kits, reagent preparation, material management and inventory control and other duties in support of manufacturing and operations. Responsible for following SOPs, performing daily tasks in a clean room/GMP environment. May also be responsible for troubleshooting manufacturing product challenges. This is a temporary position with the possibility of conversion. This posting is intended to fill two temporary positions.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to:

• Perform all duties that are required to produce reagents, intermediate consumables and finished good kits. Duties include:

  • 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

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS & ABILITIES

• Prior experience in medical devices, diagnostics (IVD), or healthcare technology in a regulated environment is preferred

• 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)

• Experience working with biological testing is a plus

• 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

• Previous experience with pipetting and filling of well-plate preferred

• 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)

• Flexibility to work overtime as required

PHYSICAL REQUIREMENTS & WORK ENVIRONMENT

This is a primarily office-based role in San Diego, CA.

COMPENSATION

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.

EQUAL EMPLOYMENT OPPORTUNITY

Genalyte, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristic.