IS Validation & Quality Analyst

The GRAAS IS team supports Amgen's Safety and Regulatory Affairs functions within Global R&D. GRAAS encompasses services responsible for the optimization of the safe use of Amgen products through continuous benefit: risk assessment and communication as well as providing regulatory and safety intelligence for the development, registration, and lifecycle management of Amgen's molecules.

The Senior Associate IS Analyst - Software Quality Assurance (short: QA Analyst) reports to the Senior Manager IS leading Amgen's GRAAS IS Program & Portfolio Management. Software Quality Assurance is to provide the means and measures for testing and - if required - validation of all the aspects of a software solution, both functionally and technically, in order to meet the requirements and overall quality of the intended solution. In addition, the QA Analyst covers the roles of Lead Problem Investigator (LPI) and oversees all system Changes within GRAAS IS.

Primary Responsibilities:

• The QA Analyst works collaboratively within the GRAAS IS team, with supporting IS functions (Infrastructure, ITIL process owners, etc.), external service providers, Corporate Quality team and business units
• The QA Analyst is responsible for supporting the planning, design and execution of system testing and validation
• Oversees or develops test plans, test cases, test scripts and test reports on multiple projects and ultimately validate that user expectations are achieved during the testing process
• Works closely with internal and external service providers to ensure the IS Problem Management process is followed. Drives problem records from initial root cause analysis to final CAPA (corrective actions/ preventative actions) and if required documents Known Errors
• Manages the portfolio of active IS Changes from initiation till closure
• Leads GRAAS IS CAB (change approval board) and ensures all changes follow the correct process
• Collaborate with cross functional IS and business teams and represent GRAAS IS as a Subject Matter Expert in the field of Software Quality Assurance, testing and validation
• Drives advancements of GRAAS IS usage of automated testing, based on ongoing analysis of manual testing efforts versus efforts to keep test automation current
• Analyze and explore industry trends and best practices in the field of responsibility
• Understand Patient Safety business processes and remain informed about changes in agency regulations
• Define and manage the change and validation approach for application support & projects
• Generates, reviews and completes validation deliverables, qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of Information Systems experience

OR

Associate's degree and 6 years of Information Systems experience

OR

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

Preferred Qualifications/ Experience:

• Proven ability to lead validation activities of complex IT GxP projects (preferably experience validating Oracle Argus and experience with Change Management Process, managing Problem records)
• Possess system quality and compliance working knowledge of GxP regulations (21 CFR Part 11); ICH GCP guidelines
• Hands-on authoring/ review/ approval of computer system validation deliverables
• Clear communicator (written and verbal) - to ensure ability to directly work with developers and other stakeholders
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
• Experience with Quality Management Software and Processes
• Author Validation Plan, Requirement/Design Specification, Installation, Qualification protocols , Traceability Matrix and Validation Summary Reports for assigned projects
• In-depth understanding of ITIL processes
• In-depth experience in all aspects of SDLC from requirements, design, testing, business analysis, data analysis and Change Control process
• 3+ years strong working experience in a regulated industry and formal (hands on) software validation experience
• Knowledge and experience in technical aspects of software solution being tested
• Business process understanding
• Working experience with IT Service Management platforms, preferably ServiceNow
• Knowledge and understanding of Information System infrastructure, system design and architecture as well as service management
• Working experience in managing global internal/ external vendor relationships
• Assist/support with regulatory inspections as well as the internal audits
• High learning agility
• Experience working with dynamic cross-functional teams and ability in decision making
• Working knowledge of GCP regulation and its applicability to PV systems