GIS Quality Analyst
Illumina - San Diego, CA

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Accountability Summary
The Global Information Services (GIS) Quality Analyst supports Illumina’s GIS Leadership Team in executing IS quality and compliance practices to cost-effectively meet strategic, operational, and legal/regulatory objectives. The Analyst executes activities that result in risk reduction, maturity of IS quality practices, operational efficiency, procedural compliance, and actionable performance measurement – all with the intent of deceasing quality costs and increasing profitability.

Specific Accountabilities
1. Acts as agent of change to help transform the IS Quality culture
2. Assesses levels of impact/risk associated with new software or changes to existing software
3. Creates, executes, and maintains test scripts to meet documented functional requirements
4. Responsible for identifying and executing regression testing activities to support current development activities
5. Works closely with developers to understand the product and track, report, and verify bugs
6. Estimates script development and execution time to support project planning activities
7. Coordinates changes and ensures required policies and standards are met in the process
8. Updates key documents such as requirements and configuration specifications; traceability matrices
9. Contributes to the development of IS quality methodologies, frameworks, and procedures
10. Ensures that deviations are resolved and that corrective and preventive actions (CAPA) are completed as planned

Skills and Technical Knowledge
1. Strong working knowledge of relevant quality regulations and frameworks – e.g., CFR 21 Part 820/11, ISO 13485, ISO 9001, CobIT 4.1, ITILv3, GAMP
2. Intermediate to advance experience conducting risk assessments and performing process and/or software quality assurance activities for a larger enterprise
3. Superior communication and problem-solving skills; ability to identify root causes and propose effective, practical solutions that deliver measurable business value
4. Excellent process analysis and design skills
5. Experience with enterprise software systems such as ERP, PLM and integration platforms. Additional weight given to sustaining experience for Manufacturing Execution Systems (MES) – specifically Camstar MES.
6. Solid business process and information architecture knowledge
7. High level of energy and commitment to driving a vision from concept to implemented solution

1. Minimum 3 years of experience in software testing/quality assurance/sustainment
2. Minimum 3 years of progressive responsibility in IS quality or technical field
3. Bachelor’s degree or higher in technology, business, or life-sciences discipline
4. Experience with innovative medical device or biotechnology company preferred

Illumina is an Equal Opportunity Employer

About this company
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Illumina elucidates the human genome. The firm makes tools used by life sciences and drug researchers to isolate and analyze...