Business Analyst II

sgs-job-4545

Information Technology
Remote
Business Analysis
SDLC
Requirements Gathering
Agile
Waterfall
GxP
21 CFR Part 11
Regulatory Applications
Functional & Non-Functional Requirements
Use Cases
Traceability Matrix
Business Process Improvement
Technical Documentation
Stakeholder Management

Contract - 05 Months Contract + (Highest possibilities of contract extension)

The IT Business Analyst will be responsible for gathering, documenting, and maintaining requirements in support of business and technical initiatives. The analyst will partner closely with technical teams to define and drive the steps required for successful delivery, ensuring execution through go-live of new systems and managing impacts to legacy and integrated platforms. This role includes ownership of updating and maintaining SDLC documentation to reflect system changes. The candidate will work with stakeholders to capture business needs, translate them into actionable requirements, define business processes and data flows, and support the delivery of key SDLC artifacts.

Job Responsibilities:

  • Support regulatory application enhancements, escalated issues, and GxP requirements.
  • Work with stakeholders to elicit and validate functional and non-functional requirements for both Agile and Waterfall projects.
  • Facilitate business requirements gathering using industry best practices.
  • Document requirements using multiple requirements writing methodologies.
  • Develop SDLC documentation including project objectives, business requirements, use cases, functional specifications, deployment plans, system documentation, and end-user documentation.
  • Collaborate with technical teams to ensure business requirements are clearly understood throughout planning, development, testing, and deployment.
  • Develop innovative solutions to complex business and technical challenges while maintaining regulatory compliance.
  • Identify and recommend business process improvements.
  • Communicate complex technical concepts and solutions effectively to business stakeholders.
  • Support stakeholder training deliverables and provide functional software support during implementations, prototypes, and pilot projects.
  • Work independently with strong attention to detail while managing multiple projects.

Skills:

  • Business Analysis
  • Requirements Gathering & Documentation
  • SDLC Methodologies
  • Agile & Waterfall
  • GxP Compliance
  • 21 CFR Part 11
  • Regulatory Systems
  • Functional & Non-Functional Requirements
  • Use Case Development
  • Traceability Matrix
  • Business Process Analysis & Improvement
  • Stakeholder Management
  • Technical Documentation
  • Analytical & Problem-Solving Skills
  • Communication & Presentation Skills
  • Project Planning & Deployment
  • Multi-tasking & Organization

Education/Experience:

  • Thorough knowledge of GxP and 21 CFR Part 11 regulations and guidelines.
  • Minimum 3–5 years of experience as a Business Analyst in the biotech or pharmaceutical industry.
  • Strong command of business analysis techniques, tools, SDLC, and iterative development methodologies.
  • Experience implementing projects within established software development life cycle methodologies.
  • Experience with regulated system projects, including requirements gathering, planning, execution, and deployment.
  • Strong analytical, creative problem-solving, and organizational skills.
  • Excellent written and verbal communication skills with the ability to present project information to management.
  • Ability to work independently, manage multiple priorities, and deliver high-quality results under pressure.

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