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
Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing. It was founded in 1983, and is headquartered in Fishers, Indiana, USA, with a workforce of 501-1000 employees. Its website is https://www.verista.com/.Company H1B Sponsorship
Verista has a track record of offering H1B sponsorships, with 1 in 2026, 7 in 2025, 4 in 2024, 13 in 2023, 6 in 2022, 1 in 2021. Please note that this does not guarantee sponsorship for this specific role.