---
title: 'Quality Assurance Specialist at Gator Bio'
canonical: 'https://feeny.ai/job/quality-assurance-specialist-gator-bio-palo-alto-rypfacncjdy0'
type: 'job'
last_seen: '2026-10-18'
---

# Quality Assurance Specialist at Gator Bio

- **Company:** Gator Bio
- **Location:** Palo Alto, CA
- **Compensation:** $70k–$95k
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-10-09
- **Last confirmed live:** 2026-10-18
- **Apply:** https://jobs.lever.co/gatorbio/567544f2-4acc-49c1-b81c-8d393c134421

## Job description

Gator Bio is a bioanalytical technology company located in Palo Alto, CA. We are creating innovative technologies to solve difficult problems facing today’s biopharma industry. We develop, manufacture, and sell instruments, biosensors, reagents, and consumables for antibody, gene, and cell therapy development.  Gator Bio’s current product portfolio includes biolayer interferometry (BLI) systems using optic fiber biosensors. We are looking for a QA Specialist to join our Quality Assurance team. The QA Specialist will play an important role in maintaining the company’s established Quality Management System (QMS), ensuring compliance with applicable quality requirements, and supporting the continuous improvement of quality system processes.

## ESSENTIAL DUTIES AND RESPONSIBILITIES

Quality Management System

- Maintain the established Quality Management System (QMS) in accordance with applicable standards and company procedures.
- Promote awareness and compliance with quality requirements across the organization.

Document and Change Control

- Manage controlled documents, quality records, forms, and other quality-related documentation.
- Manage document and change control activities, including document revisions, approvals, implementation, and periodic reviews.

Training

- Manage the quality training program, including the training matrix, training assignments, and completion tracking.
- Follow up on overdue training and maintain training records.
- Coordinate training related to quality system procedures and requirements.

Equipment Calibration and Maintenance

- Manage the equipment calibration and maintenance program.
- Monitor calibration and maintenance schedules and due dates.
- Maintain calibration and maintenance records and follow up to ensure activities are completed on time.
- Support the evaluation and documentation of out-of-calibration or out-of-service equipment.

Product Release

- Perform product and/or batch release by reviewing required quality records and documentation.
- Work with Manufacturing and QC to ensure quality requirements are completed prior to release.
- Support the investigation and resolution of quality issues that may affect product quality or release.

Quality Activities Support

- Support nonconformance (NCR), CAPA, complaint handling, and audit activities as needed.
- Perform other QA and quality-related activities as assigned.
- Maintain appropriate records and documentation for assigned quality activities.

Cross-Functional Support

- Work closely with Manufacturing, R&D, QC, Operations, and other functions to support quality activities and resolve quality issues.
- Provide timely QA support for projects and operational activities.

## QUALIFICATIONS

Required

- Bachelor’s degree in Life Sciences, Biology, Chemistry, Biochemistry, Engineering, or a related scientific or technical field.
- 2+ years of experience in Quality Assurance in a life science, biotechnology, diagnostics, medical device, or other regulated environment.
- Working knowledge of Quality Management Systems and applicable quality standards.
- Experience with quality documentation and records.
- Attention to detail and organizational skills.
- Ability to manage multiple priorities and follow through on assigned activities.
- Written and verbal communication skills.
- Ability to work effectively with cross-functional teams.

## Preferred

- Experience working in an ISO 13485, FDA-regulated, or other regulated life science environment.
- Experience performing product or batch release.
- Experience with equipment calibration and maintenance programs.
- Experience with electronic QMS or other quality management systems.
- Familiarity with GxP requirements.

Experience working in an IVD, biotechnology, medical device, or analytical instrument environment.

## PHYSICAL REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

- This role will require lengthy periods of standing and sitting.
- The employee will be required to use hands for computer work.
- Health screening: Not required

Travel: N/A

## About Gator Bio

## Company Overview
- **One-liner**: Gator Bio develops and commercializes next-generation Biolayer Interferometry (BLI) instruments, consumables, and software for label-free biomolecular analysis, enabling faster and more reliable drug discovery and life sciences research.
- **Entity Type**: Private (Other Investors)
- **Headquarters**: Palo Alto, California, United States
- **Founded**: 2001
- **Founders**: Not publicly available

## Core Business
- Primary industry/industries: Biotechnology, Life Sciences Tools & Services, Laboratory Analytical Instruments
- Target customers: B2B; pharmaceutical companies, biotech firms, academic research institutions, and contract research organizations (CROs) worldwide.
- Mission or purpose statement: "To power discoveries in the biomolecular universe, advancing the world in which we live."

## Products & Services
- **Gator® BLI Instruments (Hardware/SaaS)**: A family of label-free analysis systems based on Biolayer Interferometry that measures biomolecular interactions (kinetics, affinity, quantitation, epitope binning) without complex sample prep or fluorescent labels. Validated across 400+ installations.
- **Biosensor Consumables**: Over 30 proprietary biosensor options covering antibodies, proteins, and small molecules, designed for high reproducibility (<5% CV) and low cost of operation (up to 20 regeneration cycles).
- **Gator Bio Software (SaaS)**: Intuitive software for instrument control, data acquisition, and analysis, including AI-driven design tools for high-throughput automation and emerging applications.
- **GeneSwift Reagents (Reagents)**: A novel reagent line launched in May 2025 for genome titer and genome integrity analysis, expanding the company's offering into gene therapy analytics.

## Market Standing
- **Valuation/Market Cap**: Not disclosed (private company).
- **Key Metric**: Total funding not publicly disclosed; company is described as privately held with a round labeled "Other Investors."
- **Notable Investors/Partners**: Not publicly disclosed beyond an exclusive distribution agreement with I&L Biosystems (2022). Partners include leading pharmaceutical, biotech, and academic institutions globally.
- **Growth Signals**: +2.9% headcount growth YoY (50 employees), +24.6% LinkedIn follower growth yearly, global expansion with team members in 6 countries (US, China, Germany, Canada, Singapore, Japan), launch of GeneSwift reagents in 2025, active patent filing in 2025 for a microplate evaporation prevention apparatus.

## Competitive Advantages
- **High reproducibility**: <5% CV across runs, critical for regulatory submissions in drug development.
- **Lower total cost of ownership**: Reduced consumables cost (20+ regeneration cycles per biosensor) compared to legacy platforms.
- **Broad application range**: Covers monoclonal antibodies, gene therapies, and next-gen biologics, recently expanded into gene therapy titer analysis via GeneSwift reagents.
- **Engineer-led innovation**: Deep team of PhD-level application scientists and proprietary hardware/software design from the ground up.

## Strategic Focus
- **Innovation in BLI**: Continuously pushing boundaries with high-throughput automation, AI-driven design, and expanded applications (e.g., gene therapy analytics).
- **Global commercial expansion**: Active hiring for field application scientists and regional sales managers across US and international markets (Boston, Washington DC, and likely other regions).
- **Operational scale**: Growing from a small team of ~50 to support a larger installed base (400+ instruments) while maintaining quality and customer support.

## Why Work Here
- **Mission-driven work**: Directly contribute to accelerating breakthroughs in biotherapeutics, vaccines, diagnostics, and gene therapy for leading research institutions worldwide.
- **Collaborative culture**: Described as a team that values scientific curiosity, mutual respect, and a healthy dose of good humor—"serious about science, but never take ourselves too seriously."
- **Career growth**: Opportunities to learn, lead, and make impact across R&D, marketing, manufacturing, sales, and customer success in a growing company.
- **Work-life balance**: Generous PTO and strong commitment to employee well-being.
- **Competitive benefits**: Health, dental, vision, 401(k), life insurance, FSA, floating holidays, employee referral program, plus workers' compensation and various leave policies.
- **Remote/hybrid/office policy**: Hybrid model; some roles are remote (e.g., Field Service Engineer) while others are on-site in Palo Alto (e.g., People Operations Coordinator). HQ is in Palo Alto, CA.
- **Engineering culture**: A blend of startup energy with deep scientific expertise; team members span the globe and include scientists, engineers, and innovators.

## Sources
1. [gatorbio.com - About Us](https://www.gatorbio.com/about/)
2. [gatorbio.com - Careers](https://www.gatorbio.com/careers/)
3. [linkedin.com - Gator Bio Company Profile](https://linkedin.com/company/gatorbio)
4. [cbinsights.com - Gator Bio Profile](https://www.cbinsights.com/company/gator-bio)
5. [jobs.lever.co - Gator Bio Openings](https://jobs.lever.co/gatorbio)
6. [pharmiweb.com - GeneSwift Launch (via LinkedIn)](https://www.pharmiweb.com/press-release/2025-05-13/gator-bio-unveils-novel-new-geneswift-reagents-revolutionizing-genome-titer-and-genome-integrity-analysis)

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