Analyst, Computer System Validation
1 week ago
Join Our Team of Experts at NeoGenomics
At NeoGenomics, we are looking for a dedicated Computer Systems Validation (CSV) Analyst to help drive the growth of our company. This unique opportunity offers a hybrid position with a Monday - Friday, Day shift schedule.
Why Choose NeoGenomics?
As part of our team, you will be entrusted with a meaningful mission of contributing to the improvement of patient care and ultimately saving lives. Join us in our vision to become the leading cancer reference laboratory worldwide.
About the Role:
As a Computer System Validation (CSV) analyst, you will be responsible for planning, writing, and implementing computer Systems Validation protocols. You will utilize your expertise in GAMP5, Part 11, GxP regulatory frameworks to carry out your daily responsibilities.
Key Responsibilities:
• Creating various computer system validation (CSV) deliverables such as Validation Plans, Requirements, Design Specs, Test Scripts for IQ / OQ / PQ protocol, Summary Reports, Trace Matrices, and SOPs
• Collaborating closely with the CSV Manager, Application Manager, and SMEs to execute tasks related to IQ/OQ/PQ pre-approvals
• Ensuring the existence of local Change Requests for the effort and obtaining pre-approvals before IQ/OQ/PQ execution
• Working in conjunction with the Program/local PMs to guarantee the timely delivery of documentation
• Coordinating IQ/OQ/PQ Release approval forms for Non-GxP/GxP local applications with internal resources responsible
Experience & Necessary Qualifications:
- Completion of Formal CSV Training or possessing a background in IT/Technical field is preferred
- Hold a Bachelor's degree or higher from an accredited institution in Science, Technology, Engineering, or Math field or a related area, or possess equivalent years of significant Quality Management experience
- Minimum of 3 years of relevant experience in Computer System Validation and/or Validation remediation
- Minimum of 3 years of relevant experience in one or more functions: risk management, QMS, compliance, or privacy (experience in heavily regulated industries is a plus)
- Practical knowledge and experience with various compliance and security framework standards such as ISO 27000, PCI, HIPAA, HITECH, SOC, SOX, 21 CFR 11, CAP, CLIA, NIST, COBIT, and GDPR is preferred
- Demonstrate strong teamwork and excellent interpersonal skills
- Possess an in-depth understanding of Pharmaceutical, Medical Device, or Biotechnology Industries
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