Demo

Senior Business System Analyst

RevereIT LLC
Cambridge, MA Contractor
POSTED ON 3/11/2025
AVAILABLE BEFORE 4/9/2025

Title: Senior Business Systems Analyst

Location: Cambridge, MA


Requirements

  • 10 Years experience setting up, implementing, maintaining, enhancing, IT systems in GXP environments.
  • Proven expertise in integrating systems and data flows across varied platforms, environments, and systems.
  • Ability to drive the plan, design, and build of IT architectural solutions at the network and application level for GXP systems.
  • In-depth knowledge of CFR Part 11/GxP software qualification and data management for GXP systems.
  • Data integrity and management for GxP systems.
  • Data resiliency – backup, restore, archive.
  • Experience with annual account reviews and system periodic reviews.
  • Experience with GMP data quality assessments and managing deviations.
  • Experience in planning, documenting, and implementing IT resiliency/Disaster Recovery solutions.
  • Ability to lead; converse with the team, use collaborative skills to vet recommendations and obtain agreement.
  • Ensure technical solutions are aligned with business goals and objectives.
  • Provide technical guidance and support to business and IT teams
  • Collaborate with cross-functional teams to ensure that technical solutions are integrated with other systems.
  • Experience gathering business requirements, software testing (UAT, IQ, OQ), creating and writing SOP's and GXP validation documentation (including IT System Administration Guides).


Responsibilities:

  • Manages document creation, review, and approval for GxP and non-GxP environment and 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 and technical architecture design; validates and interprets business needs by conducting feasibility studies and drafting business cases.
  • Uses knowledge of business operations and 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.

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