6407 - Senior CSA Analyst – Plasma Systems & Site Enablement / Senor CSV Engineer
VeristaAbout the role
Description
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Senior CSA Analyst – Plasma Systems & Site Enablement Responsibilities:
Computer Software Assurance & Validation
- 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.
Compliance & Risk Management
- 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.
System Implementation & Deployment Support
- 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.
Documentation & Quality Deliverables
- 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.
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
- 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<
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