QC Scientist 1

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

We are looking for a driven and talented Quality Control Scientist to join our QC Reagent Team! This Scientist will work as part of the Reagent QC team to support Reagent QC operations. You will be responsible for testing and releasing Illumina reagents in a fast-paced, GMP regulated environment, maintaining stock of consumables in the lab, collaborating with other departments for production and non-production processes, as well as maintain a strong working relationship with supply chain and other partner organizations.

Responsibilities:

• Perform routine and non-routine analytical, biochemical, and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates, and finished goods.

• Analyze data generated at the conclusion of tests performed.

• Participate in developing and validating analytical and functional testing methodology, revising and updating work instructions and supporting documentation

• Collaborate with test method development, technical operations, and QA in the transfer of new QC test methods

• Lab execution of experiments for technical support of production testing including OOS (out of specification) and NC investigations, root cause analysis and CAPA activities

• Assist with projects around QC process improvements and qualification of changes using project management tools to achieve timelines on multiple projects with a high level of independence Ability to troubleshoot basic issues and determine a path forward to perform additional testing or corrective action during testing.

Requirements:

• Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint) essential

• Experience with writing automation protocols for liquid handling robots such as

• Hamilton a plus

• Excellent cross-functional collaboration, soft influence, written and verbal communication skills · Molecular biology laboratory skills such as multichannel pipetting, PCR, etc. required

• Ability to author and revise work instructions and perform molecular biology assays with little guidance

• Ability to respond quickly to shifting priorities and meet deadlines Preferred Skills and Experience: · GMP and FDA experience

• Other QC, process engineering, R&D or manufacturing experience will be considered

• Experience with DNA or RNA sample preparation, next-generation sequencing, qPCR, capillary electrophoresis and/or Illumina technology

• Experience with analytical assays and equipment such as UPLC, ICS, LCMS, liquid handling robots, etc.

• Understanding of medical device quality system requirements (21 CFR 820, ISO 13485, etc.) and appropriate application to quality control and manufacturing process change qualification, verification and validation activities

• Experience in data manipulation and analysis of large data sets using excel, and statistical analysis software such as JMP, minitab, etc.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Experience/Education:

• Typically requires a Bachelor’s degree and 1+ years of related experience

The estimated base salary range for the QC Scientist 1 role based in the United States of America is: $56,100 - $84,100. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics se