IS Business Analyst

The IS Business Analyst will work closely with collaborators, IS teams, and end-users to understand their requirements, analyze risks and create and review documentation.

Roles & Responsibilities:

The IS Business Analyst at Amgen India will lead requirement gathering sessions, document business processes, and create SDLC work for review. Key responsibilities include:

• Assist in testing preparation, testing, and validation
• Collaborate with collaborators to identify and document business needs and validation requirements
• Provide appropriate functional support throughout the life of the projects/products
• Serve as the main point of contact between business collaborators and technical teams during validation processes.
• Create and maintain comprehensive documentation, including requirement specifications, SOPs, manuals, validation protocols, and test cases
• Create detailed process maps and workflows to visualize current and future state processes.
• Develop change management plans and communication strategies to facilitate smooth transitions
• Train new employees on IT procedures and ensure compliance with standards
• Monitor and address any validation-related issues that arise during project execution.
• This position may have after hours responsibilities

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Masters degree and 2 years of Information Systems experience or related field OR
• Bachelors degree and 4 years of Information Systems experience or related field OR
• Associates degree and 6 years of Information Systems experience or related field OR
• High school diploma / GED and 8 years of Information Systems experience

Must-Have Skills:

• Proficient in eliciting, documenting, and managing requirements through various techniques (interviews, workshops, surveys).
• Meticulous in reviewing documentation, requirements, and validation results to ensure accuracy and compliance.
• Knowledge of documentation practices and standards required for regulatory submissions and audits.
• Experience with systems in a federally regulated environment - FDA/SOX
• Skills to identify, engage, and manage collaborators effectively throughout the project lifecycle.
• Basic project management skills to help manage timelines, resources, and collaborator expectations
• Flexibility to adapt to changing business needs, priorities, and technologies.
• Sharp learning agility, problem-solving and analytical thinking

Good-to-Have Skills:

• Familiarity with GxP, CFR 21 Part 11 and systems validation
• Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ))
• Experience with testing and validation tools, and testing frameworks
• Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies

Professional Certifications:

• Certified Business Analysis Professional (CBAP) (preferred)
• PMP Certification (preferred)

Soft Skills:

• Excellent analytical and troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully
• Good social and collaboration skills, with the ability to communicate effectively with business users, technical IT groups, project managers