Top 2 Quality assurance analyst (remote) Jobs in West Point, Pa

6407 - Senior CSA Analyst – Plasma Systems & Site Enablement / Senior CSV Engineer
Verista, Inc. —King of Prussia, PA
- $70,491 - $118,060 a year
- Remote
- Computer Science
- Engineering
- Senior level
- Commuter assistance
- Paid parental leave
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6407 - Senior CSA Analyst – Plasma Systems & Site Enablement / Senior CSV Engineer

Verista, Inc. -
King of Prussia, PA

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Job Details

$70,491 - $118,060 a year

Benefits

Commuter assistance
Paid parental leave
Health savings account
Paid holidays
Disability insurance
Health insurance
Dental insurance
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Vision insurance
401(k) matching
Referral program

Qualifications

Compliance risk assessment
Requirements specification
Bug Tracking (Quality assurance practices)
Engineering development testing
Requirements design
IT quality control
Software implementation
Quality risk management
Requirements analysis
Requirements management
Biomedical regulatory compliance
Cross-functional collaboration
Test validation method
Cross-functional communication
Test Planning (Quality assurance practices)
Validation design
IT risk management

Full Job Description

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
- Deviation management
- Validation reporting
- Release readiness processes
Ability to work independently and effectively across multiple concurrent project workstreams.

Preferred Qualifications

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
- Facility readiness initiatives
- Innovation center buildouts
- Large-scale digital transformation programs
Experience with:
- System integrations
- Data migration activities
- Interface testing
- Data flow assessments
- Reporting and downstream system impacts
Familiarity with:
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- Data Integrity requirements
- Risk-based assurance methodologies

Benefits

Why Choose Verista?

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

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

For more information about our company, please visit us at Verista.com

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