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Associate Systems Analyst - Lab Informatics System

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Amgen

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Location:
India , Hyderabad

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

In this vital role you will we are seeking a highly skilled Associate Systems Analyst to join our Quality Control Product team. You will be responsible for validation, and maintenance of software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. A significant part of this role includes ensuring that QC applications such as Sample Manager LIMS, ELN, and Empower CDS are implemented, configured, and maintained in compliance with Computer System Validation (CSV) / Computer Software Assurance (CSA) expectations. You will work closely with product managers, business SMEs, validation teams, and technical partners to deliver high‑quality, compliant, and scalable QC solutions, while ensuring system availability, audit readiness, and strong data integrity controls.

Job Responsibility:

  • Maintain existing code and configuration: Support and maintain Quality Control applications
  • CSV/CSA Support: Assist in developing and executing validation deliverables (risk assessments, test scripts, traceability matrices etc) aligned with GxP, 21 CFR Part 11, data integrity, and CSA principles
  • Documentation: Produce clear documentation for functional specs, configuration updates, validation evidence, and operational procedures to maintain system audit readiness
  • Collaborative Design: Work closely with team members and collaborators to understand project requirements and translate them into functional technical designs
  • Testing & Debugging: Contribute to unit, integration, and validation (IQ/OQ/PQ) testing activities. Troubleshoot issues in QC systems and work with validation teams to maintain compliance
  • Application Support: Perform system administration tasks - periodic reviews, access management, incident resolution, audit preparation, and change‑control documentation
  • Continuous Learning: Stay up-to-date with the newest technologies and standard methodologies, with a focus on expanding knowledge in cloud services, automation, and secure software development

Requirements:

  • Solid technical background, including understanding software development processes, databases, and cloud-based systems
  • Solid Understanding of Quality Control Platforms (Sample Manager LIMS, ELN, Empower CDS)
  • Foundational knowledge of CSV/CSA concepts including risk‑based testing, GxP requirements, and audit readiness
  • Experience working with databases, data modeling and data warehousing (Oracle, MySQL)
  • Strong understanding of testing methodologies including validation testing
  • Bachelor’s degree and 2 to 4 years of Computer Science, IT or related field experience OR Masters and 1 to 3 years of experience of Computer Science, IT or related field experience

Nice to have:

  • Understanding of Quality Control Process
  • Exposure to data integrity principles for QC instruments and informatics
  • Curiosity of modern technology domain and learning agility
  • Experience with the following technologies: AWS (Amazon Web Services) Services (DynamoDB, EC2, S3, etc.), Application Programming Interface (API) integration and Structured Query Language (SQL), Remote desktop application access management (Citrix Workspace, Middleware Experience (Mulesoft, Datadobi)
  • Superb communication skills, with the ability to convey complex technical concepts
What we offer:

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Additional Information:

Job Posted:
February 17, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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