GxP Validation Analyst jobs in United States
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UST HealthProof · 2 months ago

GxP Validation Analyst

UST HealthProof is a digital transformation company that empowers clients through innovative technology solutions. They are seeking a GxP Validation Analyst to gather and document requirements, write and execute validation test cases, and communicate effectively with various teams to ensure compliance and quality in software validation processes.

Hospital & Health Care
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H1B Sponsor Likelynote

Responsibilities

Gather and document requirements (URS, software configuration)
Write and execute validation test cases (IQ, OQ, PQ as applicable)
Perform risk assessments and ensure traceability of requirements
Support SOP migration and alignment with PPD IT practices
Communicate effectively with lab, IT, QA, and vendor teams

Qualification

Software ValidationGxP SystemsTechnical WritingEMA GuidelinesData Flow DiagramsStakeholder EngagementCSA PrinciplesCommunication SkillsDetail-oriented

Required

Strong technical writing & documentation skills
Experience in software validation (lab instruments / GxP systems)
Knowledge of EMA guidelines, Annex 11, GAMP 4
Ability to create infrastructure/data flow diagrams
Detail-oriented with strong communication and stakeholder engagement skills
Degree in Life Sciences, Computer Science, or Engineering
6–9 years relevant validation experience (pharma / biotech / CRO preferred)

Preferred

Familiarity with CSA principles is a plus

Benefits

10 days of paid vacation per year
6 days of paid sick leave each year
10 paid holidays
Paid bereavement leave
Jury duty
401(k) Retirement Plan with employer matching
Medical, dental, and vision insurance
Basic life insurance
Accidental death and disability insurance
Short- and long-term disability benefits
Voluntary short-term disability benefits
Health Savings Account (HSA)
Flexible Spending Account (FSA)

Company

UST HealthProof

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UST HealthProof offers risk adjustment, quality programs, and healthcare payer technology services. It is a sub-organization of UST.

H1B Sponsorship

UST HealthProof 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 (71)
2024 (43)
2023 (31)
2022 (3)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-09-04Acquired

Leadership Team

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Kevin Adams
Chief Executive Officer
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Beth Maxwell
VP Product Delivery and Partnerships
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Company data provided by crunchbase