Comp. Sys Validation Spec

Natera
United States
Workplace: RemoteFull timeFunction: QA, Test & Release EngineeringSkills: ["Risk management","Root cause analysis","Audit readiness","Cross-functional collaboration","Subject matter expertise"]

Ensure computer system validation documentation and controls across laboratory, product, and quality software systems. Partner with QA leadership to perform software risk assessments, review change requests and test artifacts, and draft IQ/OQ/PQ plans and reports. Lead or support CSV projects and audit readiness by acting as a subject matter expert during internal and external audits, including audit trail review and investigation of nonconformities, deviations, CAPAs, and complaints.

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FursaFursa
Natera
Natera
1 day ago

Comp. Sys Validation Spec

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Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 6 hours agoStatus: Live

Job Summary

Ensure computer system validation documentation and controls across laboratory, product, and quality software systems. Partner with QA leadership to perform software risk assessments, review change requests and test artifacts, and draft IQ/OQ/PQ plans and reports. Lead or support CSV projects and audit readiness by acting as a subject matter expert during internal and external audits, including audit trail review and investigation of nonconformities, deviations, CAPAs, and complaints.
Location: United States
Workplace: Remote
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Mid level

Key Responsibilities

  • •Participate in software risk management activities and perform risk/impact assessments for lab, product, and quality management software systems.
  • •Review software change requests and maintenance updates with associated test plans, protocols, and reports.
  • •Participate in and/or lead computer system validation projects, including drafting IQ/OQ/PQ plans, protocols, and reports.
  • •Maintain validation state of software systems and act as CSV compliance subject matter expert during internal and external audits, including audit trail reviews.
  • •Investigate and resolve software nonconformities, deviations, CAPAs, and complaints through cross-functional teams; may support quality system audits as needed.
Travel: Low travel

Pay and Benefits

Perks:Health InsuranceDentalVisionLife InsuranceDisability Insurance401kParental Leave

Key Requirements

  • •BS degree or equivalent work experience.
  • •3-5 years’ experience in a dedicated CSV or product software validation role.
  • •Experience working in a CLIA laboratory environment and/or a FDA-regulated environment.
  • •Knowledge of QA methodologies, test planning, system dependencies, and product integration phases.
  • •Regulatory knowledge for software validation/change control, including IEC 62304 and applicable US FDA and CLIA requirements.
Experience:CLIAFDA regulatedLaboratorySoftware validation
Skills:Risk managementRoot cause analysisAudit readinessCross-functional collaborationSubject matter expertise
Languages:English
Tech Stack:Microsoft Great PlainsConfluenceJIRASuccessFactorsLIMSEDMS

Company Brief

Natera
Develops and commercializes genetic testing and diagnostics focused on reproductive health, oncology, and organ transplant to inform clinical decision-making and improve patient outcomes.
Industry: Diagnostics
Company Size: Enterprise (1,001+ employees)
Revenue: USD 500M to 1B
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Carlos, United States
Founded: 2004
WebsiteLinkedIn