[Remote] 6407 - Senior CSA Analyst – Plasma Systems & Site Enablement / Senor CSV Engineer

Note: The job is a remote job and is open to candidates in USA. Verista is a team of 500 experts collaborating with leading brands in the life science industry to address significant healthcare challenges. They are seeking a Senior CSA Analyst to lead computer software assurance activities for plasma-related applications, ensuring compliance with regulatory standards and supporting validation efforts for donor operations.

Responsibilities

• Lead CSA activities for plasma-related applications and systems supporting regulated donor operations and business processes
• Develop and execute risk-based validation strategies aligned with CSA principles and industry best practices
• Support validation planning, testing, execution, and release readiness for donor-facing and operational support applications, including personalized payment capabilities
• Provide CSA oversight for Donor Management System functionality, including enhancements, integrations, configuration changes, and site-specific deployments
• Support validation and compliance activities for medical device-related systems and applications
• Apply risk-based methodologies to assess system criticality, intended use, donor impact, data integrity requirements, and regulatory compliance obligations
• Ensure validation activities align with applicable GxP requirements, quality standards, and regulatory expectations
• Evaluate system changes, enhancements, and integrations to determine validation scope and testing requirements
• Support deviation assessments, defect triage, change control activities, and documentation review processes
• Partner with IT, Quality, Operations, CSA/CSV, business process owners, and project teams to define validation approaches and testing strategies
• Support system implementation activities including: Configuration verification, Integration testing, User Acceptance Testing (UAT), Data migration and data flow assessments, Release readiness evaluations, Operational readiness activities
• Assist with cross-functional readiness efforts for systems entering regulated plasma operations environments
• Author and/or review validation lifecycle documentation, including: Risk Assessments, Validation Plans, Requirements Specifications, Test Strategies and Protocols, Traceability Matrices, Summary Reports, Change Controls
• Ensure documentation is complete, compliant, and inspection-ready
• Guide project teams on appropriate levels of testing rigor, evidence collection, and documentation based on system risk and business impact

Skills

• Bachelor's degree in Engineering, Computer Science, Life Sciences, Information Systems, or a related discipline
• Significant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA) within regulated industries
• Strong understanding of GxP computerized systems
• Strong understanding of risk-based validation methodologies
• Strong understanding of CSA principles and practices
• Strong understanding of software development and implementation lifecycles
• Experience supporting regulated system implementations, enhancements, integrations, or change management activities
• Demonstrated ability to assess system risk, define validation strategies, and drive deliverables through review and approval
• Experience collaborating with Quality, IT, Operations, business stakeholders, and technical teams
• Strong knowledge of requirements management
• Strong knowledge of test planning and execution
• Strong knowledge of traceability
• Strong knowledge of deviation management
• Strong knowledge of validation reporting
• Strong knowledge of release readiness processes
• Ability to work independently and effectively across multiple concurrent project workstreams
• Experience in plasma, blood products, biologics, pharmaceutical manufacturing, clinical operations, or medical device environments
• Experience with Donor Management Systems or comparable patient-facing, customer-facing, or operational platforms
• Knowledge of donor-facing, patient-facing, scheduling, enrollment, intake, payment, or workflow management applications
• Experience supporting medical device software, connected devices, instrumentation, equipment interfaces, or regulated data capture systems
• Experience supporting new site startups
• Experience supporting facility readiness initiatives
• Experience supporting innovation center buildouts
• Experience supporting large-scale digital transformation programs
• Experience with system integrations
• Experience with data migration activities
• Experience with interface testing
• Experience with data flow assessments
• Experience with reporting and downstream system impacts
• Familiarity with 21 CFR Part 11
• Familiarity with EU Annex 11
• Familiarity with GAMP 5
• Familiarity with data integrity requirements
• Familiarity with risk-based assurance methodologies

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Company Overview

Company H1B Sponsorship