AdeptSource · 5 hours ago
Senior CSV-QA / SQA
United States
Full-time
Remote
Senior Level, Lead/Staff
12+ years expAdeptsource is seeking a Senior CSV-QA / SQA Engineer to ensure appropriate software validation and lifecycle documentation for Laboratory and Product software systems. The role involves providing risk-based software validation guidance and representing software QA on development projects.
BiotechnologyConsultingLife ScienceProfessional ServicesStaffing Agency
Responsibilities
Provide risk-based software validation guidance throughout the CSV process for custom and COTS software following GAMP 5, FDA 21 CFR part 11, Part 820, Annex 11 and GxP requirements
Represent software QA on development projects. Perform risk assessments at system and functional levels for computerized systems
CSV documentation review/approvals including Validation Plan, URS, FS, Design Specifications, System & Functional Risk Assessment, IQ/OQ/PQ Protocol & Report, Trace Matrix, and Validation Summary Report
Review & approvals of changes and maintenance release Reports, tickets, change/release-based requirements/specs, TM, test cases/results
Experience with Computer Software Assurance (CSA)
Review & update procedures, requirements & specifications to ensure coverage of functional, configuration, design, part 11 (audit trails, eSig, access controls, etc.) and security requirements
Provide guidance and support test execution based on risk and to ensure requirements, including intended use and part 11, are tested
Ensure validation state of software systems is maintained
Act as subject matter expert for CSV compliance and regulatory requirements related to CSV while working with cross functional stakeholders
Experience and/or good knowledge of AI systems validation
Qualification
Required
BS Degree in Computer Science or similar discipline; or equivalent work experience
12+ years of experience as a dedicated CSV analyst/lead in validation of cloud-based COTS configured and customized software applications
Experience working in a CLIA Laboratory environment and/or FDA regulated environment
Provide risk-based software validation guidance throughout the CSV process for custom and COTS software following GAMP 5, FDA 21 CFR part 11, Part 820, Annex 11 and GxP requirements
Represent software QA on development projects. Perform risk assessments at system and functional levels for computerized systems
CSV documentation review/approvals including Validation Plan, URS, FS, Design Specifications, System & Functional Risk Assessment, IQ/OQ/PQ Protocol & Report, Trace Matrix, and Validation Summary Report
Review & approvals of changes and maintenance release Reports, tickets, change/release-based requirements/specs, TM, test cases/results
Experience with Computer Software Assurance (CSA)
Review & update procedures, requirements & specifications to ensure coverage of functional, configuration, design, part 11 (audit trails, eSig, access controls, etc.) and security requirements
Provide guidance and support test execution based on risk and to ensure requirements, including intended use and part 11, are tested
Ensure validation state of software systems is maintained
Act as subject matter expert for CSV compliance and regulatory requirements related to CSV while working with cross functional stakeholders
Experience and/or good knowledge of AI systems validation
Works directly with software engineering to ensure compliance of procedures to 21 CFR Part 11, CAP/CLIA/NYS, FDA Part 820, IEC62304, ISO 14971 requirements; guide planning of software verification and validation activities; perform risk and / or impact assessments for software systems
Extensive knowledge of QA methodologies, test planning, system dependencies, and software SDLC phases
Good at task execution, ability to work independently as well as in a team, with good communication skills
Company
AdeptSource
AdeptSource is an IT staffing, professional services, and consulting firm that specializes in life sciences.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Christi Kemsley
Principal/CFO
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