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

7 hours, 12 minutes ago
United States
Full-time
Senior
Program Manager
Quality Assurance and Testing
Apply Now
Verista

Verista

Verista provides transformative compliance, automation, validation, and packaging solutions for the life sciences, pharmaceutical, and manufacturing industries, ensuring consistent, safe, and high-quality results every time.

Pharmaceuticals
251-1K
Founded 2020
View All Jobs 5

Description

  • 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 enhancements, integrations, configuration changes, and site-specific deployments.
  • Support validation and compliance activities for medical device-related systems and applications.
  • Assess system criticality, intended use, donor impact, data integrity requirements, and regulatory compliance obligations using risk-based methodologies.
  • 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, business process owners, and project teams to define validation approaches and testing strategies.
  • Support configuration verification, integration testing, UAT, data migration and data flow assessments, release readiness evaluations, and operational readiness activities.

Requirements

  • 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, risk-based validation methodologies, CSA principles and practices, and 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, test planning and execution, traceability, deviation management, validation reporting, and 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 (preferred).
  • Experience with Donor Management Systems or comparable patient-facing, customer-facing, or operational platforms (preferred).
  • Knowledge of donor-facing, patient-facing, scheduling, enrollment, intake, payment, or workflow management applications (preferred).
  • Experience supporting medical device software, connected devices, instrumentation, equipment interfaces, or regulated data capture systems (preferred).
  • Experience supporting new site startups, facility readiness initiatives, innovation center buildouts, or large-scale digital transformation programs (preferred).
  • Experience with system integrations, data migration activities, interface testing, data flow assessments, and reporting/downstream system impacts (preferred).
  • Familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity requirements, and risk-based assurance methodologies (preferred).

Benefits

  • National (US) salary range of $70,491 to $118,060 USD.
  • Competitive pay plus performance-based incentive programs.
  • Company-paid Life, Short-Term Disability, and Long-Term Disability insurance.
  • Medical, dental, and vision insurance.
  • FSA, DCARE, commuter benefits, and a Health Savings Account.
  • 401(k) retirement plan with employer matching.
  • Paid time off with rollover option, holidays, and as-needed sick time.
  • Tuition reimbursement, paid parental leave, bereavement leave, employee recognition, referral program, and team social activities.

Interested in this position?

Apply directly on the company website

Apply Now

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