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.
AnalyticsArtificial Intelligence (AI)Machine LearningSoftware
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
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.
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 StageTotal Funding
$27MKey Investors
Sageview Capital
2025-06-17Series A· $27M
2016-06-01Seed
Recent News
2025-06-24
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