| Urgent req for Business System Analyst at Remote, Remote, USA |
| Email: [email protected] |
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From: Sudhanshu Shekhar, Vyze [email protected] Reply to: [email protected] Job Description -Business System Analyst USC/GC/GCEADHybrid to Cambridge, MA Job Descriptionlooking for candidates with more hands on experience with writing GxP validation documentation for both hardware/lab equipment and software, implementing lab equipment and integrating with software as needed, writing the validation documentation, take testing, performing system admin duties, etc. - 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 Keywords: information technology green card microsoft Massachusetts |
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| 01:41 AM 27-Dec-23 |