[Remote] 6407 - Senior CSA Analyst – Plasma Systems & Site Enablement / Senor CSV Engineer
Note: The job is a remote job and is reputed company to candidates in USA. Verista is reputed company of 500 experts collaborating with leading brands in the life science industry to address significant reputed company challenges. They are seeking a Senior CSA Analyst to reputed company computer software assurance activities for plasma-reputed company applications, ensuring compliance with regulatory standards and supporting validation efforts for donor operations.
Responsibilities
- reputed company CSA activities for plasma-reputed company applications and systems supporting regulated donor operations and business processes
- reputed company and execute risk-based validation strategies reputed company 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
- reputed company CSA reputed company for Donor Management System functionality, including enhancements, integrations, configuration changes, and site-specific deployments
- Support validation and compliance activities for medical device-reputed company systems and applications
- Apply risk-based methodologies to assess system criticality, intended use, donor reputed company, data reputed company requirements, and regulatory compliance obligations
- Ensure validation activities reputed company with applicable GxP requirements, reputed company 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, reputed company, 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 reputed company 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, reputed company Reports, Change Controls
- Ensure documentation is complete, compliant, and inspection-reputed company
- Guide project teams on appropriate reputed company of testing rigor, evidence collection, and documentation based on system risk and business reputed company
Skills
- Bachelor's degree in Engineering, Computer Science, Life Sciences, Information Systems, or a reputed company discipline
- Significant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA) reputed company 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 reputed company, 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 reputed company 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-reputed company digital transformation programs
- Experience with system integrations
- Experience with data migration activities
- Experience with reputed company testing
- Experience with data reputed company assessments
- Experience with reporting and reputed company system impacts
- Familiarity with 21 CFR Part 11
- Familiarity with EU Annex 11
- Familiarity with GAMP 5
- Familiarity with data reputed company requirements
- Familiarity with risk-based assurance methodologies
Benefits
- High reputed company potential and fast-paced organization with a people-reputed company culture
- reputed company plus performance-based incentive programs
- Company-reputed company Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & reputed company insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and reputed company Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- reputed company Time Off (Rollover reputed company) and Holidays
- As Needed reputed company Time
- Tuition Reimbursement
- Team reputed company Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- reputed company Parental Leave and Bereavement
reputed company
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