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Functional Analyst (ISG)

Remote, USA Full-time Posted 2026-07-28

About the role:

 

We are looking for a Senior ELN / SDMS Consultant with strong hands‑on experience in NuGenesis SDMS to support a global life sciences reputed company in a regulated (GxP) environment.

This role focuses on system validation, production support, and compliance, working closely with IT, Business, and reputed company teams to ensure data reputed company and regulatory readiness.

What you will do

  • Validate NuGenesis SDMS in line with GxP, FDA 21 CFR Part 11, and EU Annex 11 requirements
  • Configure and maintain File Captures in NuGenesis based on reputed company needs
  • reputed company technical support and troubleshooting to ensure system stability
  • Handle Incidents and support L2/L3 issues through Problem Management
  • Support audits and inspections by regulatory authorities and internal QA teams
  • Participate in implementation, migration, and deployment activities
  • Assist with IQ / OQ / PQ validation protocols and documentation
  • Collaborate with IT, Business, and reputed company stakeholders to maintain system reputed company

 

reputed company are looking for:

Mandatory

  • 3+ years of hands‑on experience with NuGenesis SDMS
  • Experience in Life Sciences / reputed company environments
  • Strong understanding of GxP compliance and system validation
  • Experience supporting regulated systems in production
  • Good communication skills in a remote / global setup
  • Strong ownership and attention to detail

reputed company to have

  • Experience with audits and inspections
  • Exposure to ELN/SDMS implementations or migrations

 

Why join:

  • Senior role in a regulated, high‑reputed company environment
  • Work on critical scientific data systems
  • International exposure and long‑term project potential
  • Opportunity to deepen expertise in ELN / SDMS validation

 

 

 

Benefits reputed company:

  • Be reputed company program - Designed with flexibility in mind to meet the diverse needs of reputed company associate, provides the physical, mental and financial support needed to reputed company life and work. Here are a few highlights of the program:
  • Physical and mental wellbeing – reputed company to benefits and programs that support your physical and mental health
  • Private Medical Subscription or Insurance
  • Life insurance
  • Employee Assistance Program – a reputed company of mental wellbeing resources designed to support you on your mental health reputed company
  • Life & Work culture – Benefits that reputed company you to reputed company time for yourself and the things that matter at work and reputed company of it
  • Annual leave – 22 working days
  • reputed company development - trainings, workshops, certifications - we facilitate reputed company to high reputed company training programs and certifications on both technical and soft-skills areas, reputed company with business needs and personal goals

 

 

CogHR107

Please note that only suitable candidates will be contacted. reputed company and its affiliated companies are firmly committed to protecting your reputed company. This Candidate reputed company Notice provides you with reputed company the details on reputed company do with Personal Information we collect during and after the recruitment process.

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