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Form of workAre you motivated to participate in a dynamic, multi-tasking environment? Do you want to join a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity.
We believe in career development and empowering our employees. Not only do we provide career coaches internally, but we offer many training opportunities to expand your knowledge base! We have highly competitive benefits with a variety of HMO and PPO options. We have company 401k match along with an Employee Stock Purchase Program. We have tuition reimbursement, leadership development, and even start employees off with 16 days of paid time off plus holidays. We offer wellness courses and have highly engaged employee resource groups. Come join the Neo team and be part of our amazing World Class Culture!
NeoGenomics is looking for aComputer System Validation Analystwho wants to continue to learn in order to allow our company to grow.
Now that you know what we're looking for in talent, let us tell you why you'd want to work at NeoGenomics:
Position Summary:
A successful candidate has practical knowledge planning, writing, implementing and review the Computer Systems Validation protocols. Must have experience in GAMP5, Part 11, GxP regulatory frameworks. Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices. Knowledge in software validation for medical devices within regulated environments.
Core Responsibilities:
- Creating Computer System Validation (CSV) deliverables (Validation Plans, Requirements, Design Specs, Test Scripts for IQ / OQ / PQ protocol, Summary Reports, Trace Matrices, SOPs)
- Work closely with the CSV Manager, Application Manager, SMEs to preform task related to IQ/OQ/PQ pre-approvals.
- Ensure local Change Requests are in place for this effort and are pre-approved before IQ/OQ/PQ execution.
- Work closely with the Program/local PMs to ensure delivery of documentation.
- Coordinate IQ/OQ/PQ Release approval forms for Non-GxP/GxP local applications with internal resources responsible.
- Drive completion/approval of deviations as they arise.
- Author, Initiate, and/or review and approve IT SOPs related to compliance
- Ensure SOPs are updated/approved to align with Go-Live for site if required.
- Provide CSV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards.
- Initiate/update GxP and Risk Assessments on system.
- Write reports summarizing System Validation activities
Requirements:
- Formal CSV Training or IT/Technical related field is preferred.
- Bachelor's degree or higher from an accredited university in Science, Technology, Engineering, or Math field or related field, or equivalent years of significant Quality Management experience.
- 3+ years relevant experience in Computer System Validation and or Validation remediation
- 3+ years relevant experience in one or more functions: risk management, QMS, compliance, or privacy preferred.
- 3+ years in heavily regulated industry preferred.
- Practical knowledge and experience with compliance and security framework standards such as ISO 27000, PCI, HIPAA, HITECH, SOC, SOX, 21 CFR 11, CAP, CLIA, NIST, COBIT, and GDPR preferred.
- In-depth knowledge of Pharmaceutical, Medical Device, or Biotechnology Industries
- Occasional travel will be required to our remote offices
