Quality Assurance Specialist

Job overview

The Quality Assurance Specialist role is onsite in Palo Alto, CA, and pays $70,000–$95,000 per year. Gator Bio develops and sells bioanalytical instruments, biosensors, reagents, and consumables for biopharma research and development. The specialist maintains the Quality Management System and supports compliance, documentation, training, equipment calibration, and product release. By coordinating with Manufacturing, QC, R&D, and Operations, the role helps ensure quality requirements are met and quality issues are addressed.

What you'll do

• Maintain the Quality Management System and promote quality compliance
• manage controlled documents and change control
• administer quality training assignments and records
• manage equipment calibration and maintenance schedules
• review quality records for product or batch release
• work with Manufacturing and QC on release requirements
• support nonconformance, CAPA, complaint handling, and audits
• maintain records and provide cross-functional QA support.

What we're looking for

Skills & competencies

quality assurance specialist

gator bio

palo alto ca

onsite

$70k–$95k/year

quality management system

document control

change control

training records

equipment calibration

product release

biotechnology

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in a scientific or technical field and 2+ years of quality assurance experience in a regulated environment; ISO 13485, FDA-regulated, product release, calibration, and electronic QMS experience are preferred.

About the employer

Gator Bio is hiring for this role. Industry: Analytical Laboratory Instrument Manufacturing. Sector: 33.