| Urgent Hiring : GxP Lab Systems Business Systems Analyst, Cambridge , MA at Cambridge, Massachusetts, USA |
| Email: [email protected] |
| From: sujata, Vyzeinc [email protected] Reply to: [email protected] Job title: GxP Lab Systems Business Systems Analyst Visa: GC & USC Location: Cambridge , MA INTERVIEW REJECTION FEEDBACK - Basically, most of the candidates that I talk to are not very well prepared for the next interviews. The bottom line is that candidates must make a better impression. Yes, your candidates as well. The complicating factor is that there is a trend that started a year or two ago in which life science companies insist on unicorn candidates. Send along any other candidates that might have more experience and display intellectual curiosity. I hope that helps. Must Have: We're looking for someone who has maybe 5 - 8 years of experience. Good energy and intellectual curiosity is important. Some leadership qualities are good, but this role is more of a doer than a leader. The role is hybrid and candidates must live within 50 miles of Cambridge MA. They are required to be in the two days/week. Most of the team comes into the office on Monday and Tuesdays, but we can be flexible as needed. Core Requirements Proven success as a business systems analyst working in a GxP environment, interfacing and liaising between IT, Business, including all levels of lab staff. and Third-Party vendors Experience gathering business requirements, software testing (UAT, IQ, OQ), creating and writing SOP's and GxP validation documentation, including IT System Administration Guides Expertise and extensive experience working on and validating lab systems in a GxP environment, for example, NC-200, XURI (Unicorn), Met One, BACT/MYLA, FACSDiva, etc. Solid understanding of key concepts and principles of data integrity and IT audit trail reviews Expertise in CFR Part 11 and GxP software validation. Understanding of data management for GxP systems. Implement and manage data integrity across lab and enterprise systems Data resiliency backup, restore, archive Audit trail review and management Performing periodic account reviews and other reviews as assigned Performing GMP data quality assessments and managing deviations Experience managing data archiving and electronic document management systems, preferably Open Lab and Veeva Quality Docs backup and restore requirements document lifecycle workflows in Veeva Quality Docs. Hands on experience with writing and executing test scripts in ALM and manually, as well as authoring test summary reports Experience with the Agile framework, scrum practices, kanban boards and Jira Nice to Have Experience working as a system administrator on Windows workstations/servers reviewing system logs, services, and settings managing asset lifecycles and environmental monitoring systems Job Description Business Analysis Uses proven history of building trusted partnerships, listening, negotiation, and persuasion to align the business and IT and ensure they meet their goals clearly documents complex business problems, proposes solutions, and documents requirements using MS Word, Excel, Visio, etc documents requirements manages business requirements within area of responsibilities Performs system administration duties as needed to support the setup and validation of GxP hardware and software Define validation scope and set priorities with the business GxP authors IT validation documents for hardware and software manages document review and approval workflows Periodic Reviews and Assessments authors and performs periodic reviews, account reviews, data Integrity assessments, audit trail reviews, and other reviews and assessments as assigned Technology Expertise Solid experience and guidance to create viable IT solutions to complex process risks, issues and problems Accountabilities Manage document creation, review, and approval process for GxP and non-GxP systems, including but not limited to lab systems Manage requirements gathering, prioritization and negotiation with business stakeholders to ensure the total solution delivered meets or exceeds expectations Maintain and influence business process design Validate and interpret business needs by conducting feasibility studies and drafting business cases Use knowledge of business operations and Business Process Mapping to articulate business processes and data flows for the purpose of operational and technical improvement Ensure delivered solutions are compliant with associated federal regulations; e,g, GMP, GxP, CFR Part 11, etc. Establish and nurture relationships with IT and business colleagues, as well as third party vendors Learn and become proficient in relevant IT processes, e.g. Change Management, Technical Operations, Lab Technical Support, Data Integrity, Compliance, CFR Part 11 etc. Work Environment Hybrid work environment where team members work from home 3 days per week and come into the Cambridge MA office twice a week. The two days per week are flexible Keywords: information technology green card microsoft Massachusetts North Carolina Urgent Hiring : GxP Lab Systems Business Systems Analyst, Cambridge , MA [email protected] |
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| Fri Aug 09 03:46:00 UTC 2024 |