Associate Systems Analyst

In this vital role you will be responsible for planning and executing software testing, supporting validation deliverables, coordinating system changes, and ensuring adherence to Amgens Computer System Validation (CSV) policies and procedures in alignment with global regulatory requirements (e.g., FDA 21 CFR Part 11, Annex 11, GAMP 5).

Computer System Validation

• Support the planning, execution, and documentation of validation activities for GxP and quality systems.
• Develop and maintain validation deliverables such as validation plans, risk assessments, test scripts, and summary reports.
• Ensure system changes follow Amgens SDLC and remain in a validated state.

Testing & Quality Assurance

• Design and execute test cases (functional, integration, regression) to verify software functionality and data integrity.
• Track and resolve testing defects and document testing evidence in compliance with GxP standards
• Support User Acceptance Testing (UAT) coordination and execution with business stakeholders.
• Change & Release Management
• Participate in change control processes, ensuring that validation impacts are properly assessed and documented.
• Review and approve change documentation aligned with Amgens IT Quality Management System (QMS).

System Support & Readiness

• Maintain validation documentation throughout the system lifecycle, ensuring traceability and audit readiness.
• Support periodic reviews, incident resolution, and audit preparations.
• Contribute to process improvement initiatives that enhance validation efficiency and system compliance.

Basic Qualifications:

• Bachelors/Masters degree with 0 to 4 years of experience in Information Systems, Computer Science, Engineering, Life Sciences, or a related discipline.

Preferred Qualifications

• Foundational understanding of GxP regulations, Computer System Validation (CSV), and Software Development Lifecycle (SDLC) in a regulated environment.
• Experience with validation testing tools (e.g., HP ALM, ValGenesis, Jira) and ITIL-based support processes (e.g., ServiceNow).
• Strong knowledge of testing methodologies and ability to author and execute test cases.
• Understanding of data integrity principles and compliance requirements (FDA 21 CFR Part 11, Annex 11, GAMP 5).
• Experience supporting Quality Systems (e.g., LIMS, QMS, eQMS, data analytics tools) or cloud-based validated applications (e.g., AWS, SaaS).
• Strong analytical skills with attention to detail and documentation quality.
• Excellent written and verbal communication skills to interface effectively with both technical and business stakeholders.

Good-to-Have Skills

• Knowledge of Quality Control (QC) and Quality Assurance (QA) processes within the biopharmaceutical industry.
• Familiarity with automated testing, data validation, or data migration verification techniques.
• Certifications such as ISTQB, GAMP 5 Practitioner, or AWS Cloud Practitioner are advantageous.

Soft Skills

• Strong analytical and problem-solving abilities.
• Excellent attention to detail and organizational skills.
• Ability to work collaboratively in global, cross-functional teams.
• High degree of initiative, accountability, and learning agility.