Associate IS Analyst – Veeva Vault Quality

Career Category

Job Description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

As part of the Veeva Vault team, you will design, develop, and maintain software applications for Amgen's Veeva Vault Quality. You will ensure the availability and performance of critical systems, collaborating with product managers, designers, and engineers to create scalable solutions. Additionally, you will automate operations, monitor system health, and respond to incidents to reduce downtime.

Roles & Responsibilities:

• Possesses strong rapid prototyping skills and can quickly translate concepts into working code.

• Lead day to day operations and maintenance of Amgen’s Veeva Vault Quality and hosted applications.

• Stay updated with the latest trends, advancements and standard processes for Veeva Vault Platform ecosystem.

• Design, develop, and implement applications and modules, including custom reports, SDKs, interfaces, and enhancements.

• Analyze and understand the functional & technical requirements of applications, solutions and systems, translate them into software architecture and design specifications.

• Develop and execute unit tests, integration tests, and other testing strategies to ensure the quality of the software following IS change control and GxP Validation process while exhibiting expertise in Risk Based Validation methodology.

• Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time.

• Maintain detailed documentation of software designs, code, and development processes.

• Work on integrating with other systems and platforms to ensure seamless data flow and functionality.

• Stay up to date on Veeva Vault Features, new releases and best practices around Veeva Platform Governance.

Basic Qualifications and Experience:

• Master’s or Bachelor's degree
• 2 to 5 years for work experience in Computer Science, Information Systems or related IT fields.

Functional Skills:

Must-Have Skills:

• Experience with Veeva Vault Quality, including Veeva configuration settings and custom builds.

• Strong knowledge of Quality Docs, QMS and Veeva Vault Manager applications and its related business processes.
• Experience in building configured and custom solutions on Veeva Vault Platform.

• Experience in managing systems, implementing and validating projects in GxP regulated environments.

• Extensive expertise in SDLC, including requirements, design, testing, data analysis, creating and managing change controls.

• Proficiency in programming languages such as Python, JavaScript etc.

• Strong understanding of software development methodologies, including Agile and Scrum.

• Experience with version control systems such as Git.

Good-to-Have Skills:

• Familiarity with relational databases (such as MySQL, SQL server, PostgreSQL etc.)

• Proficiency in programming languages such as Python, JavaScript or other programming languages

• Outstanding written and verbal communication skills, and ability to translate technical concepts for non-technical audiences.

• Experience with ETL Tools (Informatica, Databricks).

• Experience with API integrations such as MuleSoft.

• Solid understanding & Proficiency in writing SQL queries.

• Hands on experience on reporting tools such as Tableau, Spotfire & Power BI.

Professional Certifications:

• Veeva Vault Platform Administrator or Equivalent Vault Certification (Must-Have)

• SAFe for Teams (Preferred)

Soft Skills:

• Excellent analytical and troubleshooting skills.

• Strong verbal and written communication skills.

• Ability to work effectively with global, virtual teams.

• Team-oriented, with a focus on achieving team goals.

• Strong presentation and public speaking skills.

Shift Information:

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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