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Quality Assurance Specialist

  • Closed
  • US Company | Large (251-500 employees)
  • LATAM (100% remote)
  • 6+ years
  • Long-term · 40h/week
  • Enterprise software
  • Full Remote
Apply now

Required skills

  • Microsoft Office
  • veeva
  • LIMS
  • GXP
  • FDA 21 CFR 11
  • Annex 11
  • ISO 27001
  • SOX
  • HIPAA
  • HITECH
  • CLIA
  • CAP
  • Excel

Requirements

Must-haves

  • 6+ years of quality assurance experience
  • GxP experience
  • Experience in at least one of the following regulated settings: FDA 21 CFR 11, Annex 11, ISO 27001, GXP
  • Experience with computerized systems, IT processes, and regulatory compliance in clinical trials, clinical laboratory, biotech, or pharma
  • Experience in QA roles overseeing computerized system life cycles and data integrity policies
  • Proficiency with Microsoft Office (e.g., Word, Excel, PowerPoint, MS Project) and database software
  • Ability to work with minimal supervision in a fast-paced, cross-cultural environment
  • Ability to balance quality and regulatory requirements against business needs
  • Public speaking skills
  • Strong communication skills in both spoken and written English
  • Bachelor's degree in Information Technology or a related field

Nice-to-haves

  • Startup experience
  • Certified auditor accreditation or information security qualification (e.g., CISA, QICA, CISSP, CRISC, ISO 27001 Lead Auditor, SSCP)
  • Experience in at least one of the following regulated settings: SOX, HIPAA, HITECH, CLIA, CAP
  • Experience with core IT applications used in regulated environments (e.g., Veeva, LIMS)

What you will work on

  • Oversee Computer System Validation activities for newly implemented and modified systems across the full software life cycle
  • Keep computerized systems in GxP-regulated environments validated and compliant with applicable regulations (e.g. FDA 21 CFR Part 11, EU Annex 11)
  • Uphold data integrity principles throughout the system lifecycle
  • Align validation strategies with IT and system owners, overseeing documentation and on-time delivery of validation deliverables
  • Manage the life cycle of GxP computerized systems through QMS policies, documentation, and change control
  • Plan and run audits of IT and technology vendors
  • Review audit findings and validation reports to surface compliance gaps and system risks
  • Lead root cause analysis (RCA) sessions with cross-functional SMEs and approve Corrective and Preventive Actions (CAPAs)
  • Run IT supplier qualification reviews covering compliance, reliability, and data integrity practices of third-party vendors
  • Contribute to risk assessments of new and proposed technologies, including support to the Artificial Intelligence (AI) advisory team
  • Write and approve internal SOPs and processes designed for regulatory compliance (e.g. GxP, FDA 21 CFR Part 11, EU Annex 11)
  • Maintain documentation for CSV and Data Integrity projects (e.g. risk control matrices, compliance assessments, process narratives, testing, issue evaluation, reporting)
  • Handle day-to-day compliance operations (e.g. client and vendor IT questionnaires, compliance metrics, audit finding responses, internal audits, document reviews)
  • Prepare KPIs for quality reporting to management
  • Support additional QA tasks (e.g. Veeva Vault workflows, reporting, configurations)
  • Spot continuous improvement opportunities by analyzing validation processes, audit findings, and system performance metrics
  • Track evolving data privacy regulations, security strategies, and CSV compliance procedures
Apply now
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