| Sr. GxP IT Validation Business Systems Analyst | Local to MA | Hybrid at Cambridge, Massachusetts, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=730916&uid= From: Akash Mandal, trooBell Technologies LLC. [email protected] Reply to: [email protected] Hello, Hope you are doing well, We have an immediate opening for the below role, kindly please share best match profiles according to the role. Role: Sr. GxP IT Validation Business Systems Analyst Location: Cambridge MA. The candidate must be within commuting distance to Cambridge Duration: 6+ Months Interview: Video/ Phone Need LinkedIn profile link Job Description Author IT validation documents for hardware and software Complex business requirements, including diagrams as needed Standard operating procedures and IT System Guides Software test cases, scripts and reports, included but not limited to UAT, IQ, OQ Additional documentation upon request Gather, analyze, prioritize, and manage technical business requirements Engineer and test processes, and re-engineer and re-test as needed Manage document review and approval workflows Perform system administration duties as needed to support the implementation, configuration, setup and validation of GxP hardware and software Requirements: Core Experience 10 years demonstrated experience as a Business Analyst gathering and managing business requirements, authoring SOP's, GxP validation documents and IT System Admin Guides, and writing test scripts, executing tests (UAT, IQ, OQ) and writing test reports 5 years experience with GXP validation documentation (including IT System Administration Work Practices) in a life science setting Thorough understanding and experience with document review and approval workflows, and global electronic document management systems Proven aptitude for creating and nurturing trusted relationships with colleagues from IT, business and lab staff at all levels of the organization third-party vendors Familiar with data integrity and archiving Demonstrated knowledge and experience working as a system administrator on Windows workstations/servers reviewing system logs, services, and settings with asset lifecycle management and environmental monitoring systems Solid understanding of and experience with Agile, Scrum, and Kanban concepts Expertise in CFR Part 11/GxP software qualification. Solid understanding of data management and integrity best practices for GxP hardware and software systems Excellent oral and written communication skills Ability to build trust with business, lab and IT stakeholders at all levels of the organization Strong presentation skills Nice to have Hands on experience AWS as backend/storage Experience with OpenLab, Veeva Quality Docs, MS ALM and/or SAP Experience working as a system administrator on Windows workstations/servers reviewing system logs, services, and settings with asset lifecycle management and environmental monitoring systems Accountabilities Manages requirements gathering, prioritization and negotiation with business stakeholders to ensure the total solution delivered meets or exceeds expectations Analyze complex business problems Author IT validation documents for hardware and software, manages document review and approval workflow Work with the business to define validation scope and set priorities. Perform system administration duties as needed to support the setup, maintenance, management and validation of GxP hardware and software Manage and track document creation, review, and approval workflows for GxP and non-GxP systems, including but not limited to lab systems, hardware, and software Implement and manage best data integrity, resiliency (backup, restore and archive) and audit trail practices across hardware, on prem software and enterprise systems Create and manage audit trails Perform annual account reviews, periodic reviews Perform GMP data quality assessments and manage deviations Maintain and influence business process design Conduct feasibility studies and draft business cases to understand and validate business needs Write test cases and scripts, execute tests (UAT, IQ, OQ) and write reports manually and in MS ALM Improve operational and technical processes and practices using knowledge of business operations and Business Process Mapping to articulate business and data flows Ensure delivered solutions are compliant with associated federal regulations (GMP, GxP) Creating and nurture trusted relationships with colleagues from IT, business and lab staff at all levels of the organization third-party vendors Learn and become proficient in relevant IT processes; including but not limited to change management, technical operations, lab technical support Work Environment: Hybrid work environment where team members work from home and come into the office at leastseveral times each month for meetings and working in the labs. Thanks, and Regards Akash Mandal | Technical Recruiter Email | trooBell Technologies LLC. Address: 9420, River Lake Drive, Roswell, GA, 30075 Keywords: information technology card microsoft Georgia Massachusetts http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=730916&uid= |
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| 12:38 AM 10-Oct-23 |