[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