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Sr Associate Information Systems Business Systems Analyst

Employer
Amgen
Location
Tampa, FL, US
Start date
May 23, 2019

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Job Details

Amgen is seeking a Business Systems Analyst to join Operations Information Systems (OIS) team. The Analyst will report to the Senior Manager for Quality and Regulatory Systems.

The System Analyst will be responsible for providing Information Systems (IS) technology leadership for the Quality and Regulatory functions. The System Analyst will be the primary IS contact and subject matter expert for specific business capabilities within the Quality Organization and will interact frequently with Quality and Regulatory business partners, IS & Quality management, and service delivery partners to improve business capabilities and proactively manage our technology roadmaps.

The Operations Information Systems team supports the Quality, Manufacturing, Supply Chain and Process Development functions to ensure they have the systems and processes necessary to supply lifesaving products to Amgen's Patients around the globe.

Key responsibilities include:
  • Partner with Quality and IS subject matter experts to develop and proactively manage technology Roadmaps including new business capabilities, new technologies, software and infrastructure upgrades, SaaS platforms and critical security features.
  • Accountable to deliver IS service in alignment with business and IS strategy.
  • Translate business requirements into functional and non-functional application and service requirements.
  • Actively engage with business users to analyze business needs, identify technology solutions gather and document design guided by best practices in Agile solution development.
  • Serve as lead Solution Engineer: Lead in-house solution development as well as oversee supporting team of external contractors and consultants.
  • Review project deliverables throughout development to ensure quality and traceability to requirements and adherence to all quality management plans and standards. Participate in IS quality validation reviews.
  • Manage, refine and prioritize the backlog of requirements/user stories.
  • Provide subject matter expertise in the event of internal and external audits.
  • Ensure business continuity during critical production issues and ensure the problem management process is effectively followed for root cause, corrective actions, and preventative actions.
  • Manage service delivery partners to ensure system availability per SLA's and implement proactive measures to reduce the number of incidents and unplanned outages.
  • Guide project planning, resource allocation, troubleshooting and resolution of complex issues.
  • Support day-to-day sustainment and production run support activities.


Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of Project Management and Information Systems experience

OR

Associate degree and 6 years of Project Management and Information Systems experience

OR

High school diploma / GED and 8 years of Project Management and Information Systems experience

Preferred Qualifications
  • Strong verbal and written communication and interpersonal skills.
  • Experience with global Quality Management Processes including Non-Conformance Management, Corrective and Preventative Action, Change Control, Product Complaints, Supplier Quality Management, Contract Manufacturing Management, Learning Management and Document Management.
  • Good overall understanding of business, manufacturing, and laboratory systems common in the pharmaceutical industry, as well as the integration of these systems through applicable standards.
  • Understanding of FDA regulations governing computer system validation and operation in biotech manufacturing and laboratory areas.
  • Extensive experience in an GxP regulated industry.
  • Knowledge of Trackwise or other Quality Management Systems.
  • Experience with Salesforce or Amazon Web Services (AWS) or SaaS platforms is a plus.
  • Experience with Big Data and Analytics is a plus.
  • Demonstrated ability to organize, manage, and direct cross-functional teams to address and solve business and technical issues.
  • Exceptional problem-solving skills.
  • Project management and business analysis experience.
  • Demonstrated ability to coordinate/lead multiple projects/activities with competing priorities.


Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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