| Life Sciences GxP BA - SAP at Cambridge, Massachusetts, USA |
| Email: [email protected] |
| Role: Life Sciences GxP BA - SAP Location: Cambridge, MA (Hybrid) Interview: Video Duration: 6+ Months Contract No H1B/OPT/CPT About the job Job Description - Requirements - Core Experience -- 10 years experience gathering business requirements, software testing (UAT, IQ, OQ), creating and writing SOP's -- 5 years experience with GXP validation documentation (including IT System Administration Work Practices) in a life science setting -- 5 years experience implementing SAP modules, including integrations with other software -- Thorough understanding and experience with document review and approval workflows, data archiving, and global electronic document management systems -- Demonstrated history of writing and executing test scripts and authoring test reports, manually and in MS ALM -- Proven success as a business systems analyst, working in a GxP environment -- Aptitude for creating and nurturing trusted relationships with colleagues from the IT and business teams and third-party vendors -- 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 -- Excellent oral and written communication skills -- Ability to negotiate and persuade at all levels of the organization -- Strong presentation skills - Major Pluses -- Hands on experience AWS as backend/storage -- Experience with OpenLab and Veeva Quality Docs Accountabilities - Manages document creation, review, and approval for GxP and non-GxP systems including but not limited to lab systems - Manages requirements gathering, prioritization and negotiation with business stakeholders to ensure the total solution delivered meets or exceeds expectations - Maintains and influences business process design; validates and interprets business needs by conducting feasibility studies and drafting business cases -- Uses knowledge of business operations and uses Business Process Mapping to articulate business and data flows for the purpose of operational and technical improvement -- Ensures delivered solutions are compliant with associated federal regulations (GMP, GxP) -- Establishes and nurtures relationships with relevant colleagues from the IT and business teams -- Learn and become proficient in relevant IT processes, e.g., Change Management, Technical Operations, Lab Technical Support -- Owns the creation and maintenance of documents for the CTMF data management and server strategy Work Environment Hybrid work environment where team members work from home and come into the office at least several times each month for meetings and working in the labs Thanks & Regards Gurpreet Singh Technical Recruiter : [email protected] Desk No - 980-294-7418 || Ext. No: 1018 Cloud Space LLC Website : www.cloudspacetek.com Address : 1909 J N, Pease Place, Suite 201, Charlotte, NC 28262 -- Keywords: business analyst information technology microsoft Massachusetts North Carolina |
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| Tue Oct 10 02:18:00 UTC 2023 |