Jobs · Quality Assurance · New York

Analytical Systems Validation Specialist

WaveCrest Staffing Group · Rensselaer, NY · 1 wk ago
Quality AssuranceFull-time

About the role

Our client, a leading organization in the pharmaceutical and life sciences industry, is seeking a Analytical Systems Validation Analyst to join their growing team. This is an excellent opportunity for an IT professional with experience supporting analytical instruments, laboratory software, and regulated computer systems to play a key role in quality, compliance, and validation initiatives. FULLY ONSITE ROLE

Responsibilities

  • Lead and support multiple computer systems validation projects across site and global programs
  • Develop and execute validation documentation, including risk assessments, protocols, reports, templates, and SOPs
  • Partner with stakeholders to ensure validated systems meet business and regulatory requirements
  • Manage CSV-related change controls, CAPAs, deviations, and quality events
  • Serve as a subject matter expert during audits and inspections
  • Maintain inventories of laboratory software, scientific applications, and computerized systems
  • Support system compliance activities, including patching assessments, antivirus management, backups, and operating system upgrades
  • Generate routine compliance, project status, inventory, and audit remediation reports

Requirements

  • Bachelor's degree in Information Technology or a related field
  • 2-3+ years of experience in Computer Systems Validation (CSV), IT, or quality systems within a regulated environment
  • Experience supporting analytical instruments and laboratory software applications
  • Strong understanding of computer system lifecycle management, data integrity, and compliance requirements
  • Pharmaceutical, biotechnology, or GMP industry experience is highly preferred

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