Senior Associate IS Business Systems Analyst
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Job Details
Job Posting Title
Sr Associate IS Business Systems Analyst
Job Profile
Sr Associate IS Bus Sys Analyst
Job Description
Join Amgens Mission of Serving Patients At Amgen, if you feel like you are part of something bigger, its because you are. Our shared
missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our
fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare
Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients
as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is
collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as
part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What you will do
Lets do this. Lets change the world. In this vital role, you will work with cross-functional teams to support GRC processes for IS and GxP.
You will monitor GxP records, support IS CDOCs document management, assess potential compliance risks, track remediation actions, and
contribute to regulatory compliance through evidence collection and reporting. You will also troubleshoot issues, support end users, and contribute to IT projects and process improvements.
Roles Responsibilities:
GRC Monitoring and Risk Support
Identify and assess potential compliance risks through GxP and IS CDOCs monitoring, and escalate concerns to the process owner.
GxP Compliance Support
- Monitor GxP deviation, CAPA, and CAPA-EV records for status, due dates, completeness, and required follow-up.
- Follow up with record owners on routine actions and escalate overdue items, gaps, or potential compliance concerns to the process owner.
- Respond to routine GxP process questions and guide users on record requirements and established procedures.
- Support GxP office hours, process guidance sessions, and stakeholder meetings; help identify recurring questions or process issues.
IS Document Management (CDOCs)
- Review IS CDOCs reports and workflows to track open actions, aging documents, upcoming periodic reviews, and approval or routing issues.
- Follow up with document owners and stakeholders to support timely reviews, revisions, and approvals.
- Provide routine process guidance to document owners, authors, reviewers, and approvers on established CDOCs requirements.
- Support document traceability, version control, office hours, and stakeholder meetings; escalate workflow or compliance issues as needed.
Stakeholder Communication
Collaborate with IS, cybersecurity, quality, and business stakeholders to resolve issues and support process needs.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications Experience:
Bachelors degree and 59 years of relevant experience in computer science, information technology, cybersecurity, risk management, or a related field;
Functional Skills:
Must-Have Skills:
- Solid understanding of IT infrastructure, systems, and standard processes.
- Excellent problem-solving, analytical, and communication skills.
- Hands-on experience with electronic document management systems (e.g., Veeva/CDOCs) and quality management systems (e.g., TrackWise) in regulated environments.
Good-to-Have Skills:
- Ability to understand and interpret policies, standards, and regulatory requirements (e.g., CDOCs, GxP, FDA 21 CFR Part 11) with guidance.
- Knowledge of Computer System Validation (CSV)
- Awareness of reporting, automation, or AI-enabled approaches to improve IS process efficiency and documentation quality.
- Experience with ChatGPT or Copilot.
- Experience with SharePoint.
Soft Skills:
Strong verbal and written communication skills
Ability to work effectively with global, virtual teams
Ability to manage multiple priorities successfully
Team-oriented, with a focus on achieving team goals
Strong presentation and public speaking skills
Type-Full time
Scheduled Weekly Hours-40
Work Shift-Flexi Shift (India)