Manufacturing Technician I — GMP/ISO Kit Assembly

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

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.