Job Summary:

This position requires an individual who will work under direct supervision to support change and configuration activities of products from inception through end-of-life. This person will join a dynamic, fast paced organization supporting new product development teams, as well as sustaining operations. This person is responsible for compiling relevant information related to product and process definition, analyzing business and compliance requirements, assessing risks for impact, and procuring accurate information for use in global systems. In addition to product configuration and change activities, tasks include support and iteration of Laboratory Information Management System (LIMS) models, development of Statistical Process Control (SPC) trending dashboards and maintenance of the Quality Control (QC) trending program, development and maintenance of QC analytical and functional methods in LIMS, workflow process development, and identification and participation in product and process improvements initiatives.

Responsibilities:

• Own, support, and iterate models in LIMS to develop and optimize QC process flows
• Support improved utilization of LIMS for a QC laboratory area with respect to both configuration and core functionality, and act as "voice of the customer" for QC
• Develop and maintain product specific SPC trend dashboards in Reagent Quality Control
• Understanding of master data and the roles played by PLM, ERP, MES, LIMS, etc. in support of manufacturing and product release
• Engage Subject Matter Experts (SMEs) to assure change and configuration documentation is accurate and complete, all relevant documentation is included, and appropriate implementation strategies and validation activities have been completed.
• Review and monitor implementation activities to ensure the change has been completed properly
• Support process improvement initiatives of varying complexity engaging global, cross-functional support
• Able to work independently and requires minimal guidance to perform required tasks
• Work with peers and/or subordinates to ensure timely completion of projects and tasks
• Demonstrate effective communication style working with all levels of organizational structure, through multiple departments, and across global sites

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities

Requirements

• Direct hands on experience creating and supporting modeling in LIMS, LabVantage LIMS preferred, but not required.
• Direct hands on experience creating and supporting SPC trend dashboards, Northwest Analytics (NWA) preferred, but not required.
• Technical background in QC, preferably in a life sciences, diagnostic, and/or medical device environment
• Understanding of computer system and QC validations preferred
• Experience with Software Development Life Cycle of quality systems preferred
• Working knowledge of ISO 13485 and cGMP requirements desired
• High degree of initiative and ownership, as well as a proven history of delivering results while working with several different departments in a fast-paced environment

Education/Experience

Bachelor's degree preferred but related technical certification and experience considered.

Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions) beginning November 1, 2021.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf