Precision Assembly & QC Technician — Medical Devices

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

Job summary

Genalyte, Inc. is seeking an on-site manufacturing technician in San Diego, CA to assist with assembly, packaging, and reagent preparation in a GMP environment.

This temporary role supports manufacturing and operations, with potential conversion based on performance and business needs. Under supervision, you will handle manual and semi-automated tasks, maintain inventory, document batch records, and ensure compliance with cGMP, ISO 13485, and 21 CFR part 820 requirements.

Qualifications

• Experience in a regulated FDA environment is preferred.
• High School education or GED with 3+ years in FDA-regulated environment and basic lab operations.
• Experience with biological testing is a plus.

Responsibilities

• Assemble and package kits and reagents in a GMP-clean room.
• Maintain inventory accuracy and material management to ensure timely replenishment.
• Complete batch records and related manufacturing documentation.
• Follow SOPs, PPE, and safety procedures; report discrepancies to leadership.
• Operate with attention to small components, pipetting, and QC verification.

Skills

Attention to detail

Manual dexterity

English communication

Pipetting

Math calculations

Education

High School diploma or GED

Tools

Tweezers

Basic lab tools

Job description

Genalyte, Inc. is seeking an on-site manufacturing technician in San Diego, CA to assist with assembly, packaging, and reagent preparation in a GMP environment.

This temporary role supports manufacturing and operations, with potential conversion based on performance and business needs. Under supervision, you will handle manual and semi-automated tasks, maintain inventory, document batch records, and ensure compliance with cGMP, ISO 13485, and 21 CFR part 820 requirements.