Validation Specialist

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🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $61.5k - $96.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 0%

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ARC-One Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

Healthcare • Manufacturing • Logistics

ARC-One Solutions is creating a next-generation Blood Establishment Computer Software (BECS) platform designed to support safe, efficient, and compliant regulated blood supply chain management. Formed through a partnership between two of the largest blood centers in the country, ARC-One Solutions plays a crucial role in fulfilling over 50% of the nation’s blood supply needs. With a focus on quality and compliance, their software provides robust solutions for blood collection, manufacturing, and distribution management, ultimately contributing to saving lives.

📋 Description

• Serve as the validation subject matter expert for an Agile Team by providing business workflow clarification, validation guidance and regulatory context. • Develop behavior-driven development scenarios and support automated and manual test coverage aligned with acceptance criteria, intended use, applicable standards and industry practices. • Clarify documented business processes, user workflows, dependencies, risks and acceptance criteria when the Product Owner is unavailable, escalating decisions requiring formal Product Owner accountability. • Participate in and facilitate PI planning, backlog refinement, iteration planning, reviews, retrospectives and other Agile ceremonies. • Proactively prevent defects by embedding quality at the source and incorporating validation, risk, regulatory, traceability and testability considerations early in development. • Review user stories, defects, features, enablers and other work items to ensure appropriate acceptance-criteria and test-scenario coverage. • Collaborate with Product Managers, Product Owners, Agile team members and other stakeholders to ensure work supports intended use and agreed business value. • Create and refine user stories, defects, acceptance criteria and test scenarios from a software verification and validation perspective. • Develop risk-informed test scenarios covering representative use, normal and exception workflows, and negative and boundary conditions. • Support automated testing, review test output and confirm results are complete, objective and acceptable across applicable environments. • Drive clear, testable and risk-informed acceptance criteria for user stories and defects. • Perform ad hoc and workflow-based exploratory testing to identify defects, requirement ambiguity, workflow conflicts, validation gaps and documentation concerns. • Support validation planning, documentation, review, execution and evidence retention in accordance with quality system procedures. • Promote quality, inspection readiness, shared ownership and continuous improvement while mentoring cross-functional team members on validation expectations.

🎯 Requirements

• Bachelor’s degree from an accredited college or university. • Five (5) years of experience in regulated quality assurance, a blood bank environment, software testing, business analysis, validation, or an equivalent combination of education, training, and experience. • SAF(e) Agile certification, training, or practical Agile team experience preferred. • Experience supporting Agile teams through PI planning, backlog refinement, iteration planning, user story creation, acceptance criteria development, and test scenario review preferred. • Ability to analyze and document complex business processes, user workflows, risks, and system behavior as user stories, acceptance criteria, and validation scenarios. • Ability to serve as a validation subject matter expert and provide clear guidance regarding blood bank workflow and user needs. • Working knowledge of software verification and validation practices, traceability, risk-based testing, defect management, change impact assessment, and objective evidence expectations in a regulated environment. • Knowledge of FDA-regulated software quality expectations, quality system procedures, SOP compliance, software development life cycle principles and quality assurance methodologies preferred. • Ability to evaluate user stories, defects, acceptance criteria and test evidence to determine whether validation coverage is adequate, traceable and objective. • Strong analytical, facilitation, collaboration, communication and problem-solving skills, including the ability to explain technical, regulatory and workflow concepts in clear, non-technical terms. • Ability to manage multiple priorities and remain flexible when sprint commitments, priorities or work direction change. • Must have reliable internet connection at all times. • Must be able to travel 10% of the time.

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