Computer Systems Validation Specialist (GxP) jobs in United States
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Uncountable Inc. · 2 months ago

Computer Systems Validation Specialist (GxP)

Uncountable is looking for a GxP Validation & QA Specialist to help execute test cases and develop documentation for their GxP Validation Kit. The role involves collaborating with QA, Product, and Engineering teams to ensure validation efforts meet GxP and audit standards.

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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Execute functional and validation test cases within our ELN/LIMS platform
Record test results, screenshots, and evidence following GxP documentation requirements
Create and maintain validation deliverables such as test reports, deviation logs, and traceability matrices
Review and improve test case design and documentation templates
Support internal QA and compliance processes, contributing to continuous improvement of our Validation Master Plan (VMP) and validation package structure

Qualification

GxP validationSoftware testingQuality assuranceSoftware validation lifecycleELN/LIMS experienceJiraGoogle Workspace21 CFR Part 11ISO 13485/9001Attention to detailWritten communication

Required

Experience with GxP validation, software testing, or quality assurance in a regulated life sciences or pharma environment
Familiarity with software validation lifecycle concepts (IQ/OQ/PQ, VMP, traceability)
Excellent attention to detail and strong written communication skills
Comfort working in a remote, fast-paced SaaS environment
Familiarity with tools like Jira and Google Workspace

Preferred

Experience with ELN/LIMS, QMS, or related lab informatics systems
Experience authoring or reviewing validation documentation for SaaS or cloud-based software
Knowledge of 21 CFR Part 11, Annex 11, or ISO 13485/9001
Prior experience working with validation kits or customer-facing qualification documentation

Benefits

Flexible, remote-first culture
Potential for full-time conversion with growth opportunities in QA, compliance, or validation management

Company

Uncountable Inc.

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Uncountable helps the world’s largest manufacturers drive innovation.

H1B Sponsorship

Uncountable Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2021 (1)
2020 (2)

Funding

Current Stage
Growth Stage
Total Funding
$27M
Key Investors
Sageview Capital
2025-06-17Series A· $27M
2016-06-01Seed

Leadership Team

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Jason Hirshman
Co-Founder
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Noel Hollingsworth
Co-Founder
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Company data provided by crunchbase