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Computer System Validation Remote Jobs in Washington

Valspec

QA Consultant

Rockville, MD · Remote

Valspec--a global provider of system validation and lifecycle services--provides commissioning and ... Remote Employment Type: Contract / Consulting (6-12+ months) Start Date: ASAP About the Role: We ...

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Computer System Validation Remote information

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) professional working remotely, and why are they important?

To excel as a Computer System Validation Remote professional, you need a solid understanding of regulatory compliance (such as FDA 21 CFR Part 11), risk management, and validation lifecycle processes, often supported by a degree in computer science, engineering, or a related field. Familiarity with validation software, quality management systems (QMS), and documentation tools is typically required, along with certifications like GAMP or Six Sigma being advantageous. Strong attention to detail, analytical thinking, and effective remote communication are crucial soft skills for this role. These competencies ensure validated systems meet compliance standards, minimize risks, and support seamless collaboration in a regulated, distributed environment.

What are some common challenges faced by Computer System Validation professionals working remotely, and how can they be addressed?

Remote Computer System Validation (CSV) professionals often encounter challenges such as coordinating validation activities across distributed teams and ensuring secure access to sensitive documentation. Effective communication and use of collaborative tools are crucial for managing documentation reviews, test execution, and issue resolution. Establishing clear validation protocols and regular virtual check-ins with cross-functional teams can help maintain compliance and project momentum. Additionally, leveraging secure cloud-based validation platforms can streamline approvals and maintain data integrity while working remotely.

What is computer system validation (CSV) in a remote job context?

Computer system validation (CSV) is a process used to ensure that IT systems and software used in regulated industries (such as pharmaceuticals or healthcare) work as intended and comply with relevant regulations. In a remote job context, CSV professionals perform validation tasks, documentation, and system testing from an offsite location, often collaborating with teams via digital tools. This remote work typically involves reviewing validation protocols, writing reports, and ensuring compliance with standards like FDA 21 CFR Part 11, all while leveraging secure online platforms to communicate and manage documentation.

What is the difference between Computer System Validation Remote vs Computer System Validation on-site?

AspectComputer System Validation RemoteComputer System Validation on-site
Work EnvironmentPerforms validation tasks remotely, often from home or a different location from the client site.Works directly at the client or company site, conducting validation activities in person.
Required CredentialsTypically requires certifications like GxP, 21 CFR Part 11, and validation experience, applicable in both settings.Same certifications as remote roles, with additional familiarity with on-site equipment and facilities.
Industry UsageCommon in industries like pharmaceuticals and biotech where remote oversight is feasible.Traditional in regulated industries requiring on-site validation activities.

Both roles require similar certifications and industry knowledge, but the main difference lies in the work environment—remote versus on-site. Remote validation offers flexibility, while on-site validation involves direct interaction at the facility.

What are the most commonly searched types of Computer System Validation jobs in Washington? The most popular types of Computer System Validation jobs in Washington are:
What are popular job titles related to Computer System Validation Remote jobs in Washington? For Computer System Validation Remote jobs in Washington, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Remote jobs in Washington look for? The top searched job categories for Computer System Validation Remote jobs in Washington are:
What cities in Washington are hiring for Computer System Validation Remote jobs? Cities in Washington with the most Computer System Validation Remote job openings:
Computer System Validation Remote jobs near you
Medical Records Management Testing & Validation Consultant (Part Time, Remote)

Medical Records Management Testing & Validation Consultant (Part Time, Remote)

TestPros

Sterling, VA • Remote

Other

Posted 4 days ago

Job description

Company Overview:

TestPros is a successful and growing business, established in 1988 to provide Information Technology (IT) technical support services to a wide range of Commercial and U.S. Federal, State, and Local Government customers. Our capabilities include Program Management, Program Oversight, Process Audit, Intelligence Analysis, Cyber Security, NIST 800-53, NIST SP 800-171 / CMMC Consulting/Assessment/Compliance, PCI Compliance, HIPAA, SOC 2, GLBA, Zero Trust, Resiliency, Computer Forensics, Software Supply Chain Assurance, Software Testing, Test Automation, Section 508 and WCAG Accessibility Assessment and Remediation, Localization Testing, Independent Verification and Validation (IV&V), Quality Assurance (QA), Compliance, and Research and Development (R&D) services. TestPros is an Equal Opportunity Employer.

Position:  Part time (as needed, 1099 or Corp. to Corp)
 

Position Summary

We are seeking an experienced Testing & Validation Consultant to support hands-on testing and compliance validation of a medical records management and electronic document management application operating within a regulated healthcare and/or FDA-related environment.

The consultant will perform functional, security, compliance, privacy, and data integrity testing of systems managing sensitive healthcare and electronic records. The ideal candidate will have experience validating applications against regulatory and records management standards including HIPAA, FDA 21 CFR Part 11, ISO 16175-1, and ISO 14641.

This role is focused on practical testing and validation activities rather than high-level IV&V oversight only.

Key Responsibilities
  • Perform hands-on functional testing of medical records management or electronic records applications
  • Execute compliance validation activities related to HIPAA, FDA 21 CFR Part 11, ISO 16175-1, and ISO 14641 requirements
  • Review system functionality related to:
    • Electronic records management
    • Electronic signatures
    • Audit trails and audit logging
    • Access controls and user permissions
    • Encryption and secure transmission
    • Data retention and traceability
    • Privacy and protected health information (PHI/ePHI) handling
  • Develop and execute:
    • Test plans
    • Test cases
    • Validation scripts
    • Traceability matrices
    • Defect reports
    • Compliance validation documentation
  • Validate data integrity, record authenticity, retention, and system security controls
  • Review prior internal validation documentation and enhance or develop updated testing documentation
  • Coordinate with stakeholders to identify testing scope, compliance objectives, and remediation priorities
  • Document findings, risks, gaps, and recommendations
Required Experience
  • Experience testing or validating:
    • Medical records systems
    • Electronic document management systems (EDMS)
    • Electronic health record (EHR/EMR) systems
    • Records archive or controlled electronic records applications
  • Hands-on experience with software testing and validation in regulated healthcare, pharmaceutical, biotech, medical device, laboratory, or records management environments
  • Strong understanding of:
    • HIPAA Privacy Rule
    • HIPAA Security Rule
    • FDA 21 CFR Part 11
  • Experience validating:
    • Electronic records
    • Electronic signatures
    • Audit trails
    • Access controls
    • Security safeguards
    • Data integrity controls
  • Experience developing and executing functional and compliance test cases
  • Ability to analyze regulatory requirements and translate them into testable validation criteria
Preferred Experience
  • Experience with ISO 16175-1:2020 functional requirements for digital records management systems
  • Experience with ISO 14641:2018 electronic document preservation and traceability requirements
  • Experience performing privacy reviews and compliance assessments involving PHI/ePHI
  • Experience supporting FDA-regulated or GxP environments
  • Familiarity with records retention, legal admissibility, and long-term digital preservation requirements
  • Experience supporting validation documentation for audits or regulatory reviews
Testing Areas of Focus
  • Functional testing
  • Security testing
  • Compliance validation
  • Privacy and data integrity review

Performance/load testing is not currently required.

Deliverables
  • Test plans and test cases
  • Validation protocols and scripts
  • Compliance assessment documentation
  • Defect and remediation reports
  • Final validation summary/report

TestPros, Inc. is an Equal Opportunity Employer.

EEO Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, marital status, age, national origin, or protected veteran status.

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