Job Description

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.

Position Summary:

This position is responsible for Quality activities that improve, monitor and measure Illumina\xe2\x80\x99s compliance with the Quality System Regulations, Illumina Quality policies, FDA regulations and ISO standards as well as Illumina product quality for current operation and compliance objectives.

It includes a wide range of activities related to process improvement, ensuring all work is completed accurately within specified time frames, and making sure high levels of customer service are provided at all times. At the direction of the QC Ops Manager, coordinate and execute all aspects of QC operational activities and improvements. These individuals will provide technical leadership to ensure timely delivery of QC activities.

Position Responsibilities:

• Perform analytical testing on HPLC, Spectramax, qPCR equipment
• Perform DNA library preparation assay for sequencing testing
• Assist in OJT template creation for training, coaching to technicians and compliant to procedures/protocols
• Establishment of On-The-Job Training (OJT) for QC processes
• Identify and implement activities to improve Turn-around-time (TAT) operational excellence and First Pass Yield (FPY) within QC and alignment across departments
• Revising and updating Standard Operating Procedures, system or processes to improve compliance, efficiency and execution
• Assignment may include but not limited to overseeing processes such as non-conformance material, incoming and outgoing inspection, return material authorization, calibration, analytical or bio-molecular QC assays to support release, characterization and stability testing of raw materials, production intermediates and final goods etc
• Assist in developing procedures, work instructions, guidance, best practice protocol such as checklists and troubleshooting guidelines
• Assist in conducting and documenting investigations for OOS results and other discrepancies. May perform troubleshooting on discrepancy observed in laboratory or material as necessary
• Assist in functional testing and qualification run for new/modified product/method equipment and engineering studies if required
• Support process FMEA and Risk Analysis on the Reagent QC processes/activities on existing PNs and new NPIs transfers
• Able to use laboratory information management system (LIMS)
• Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits
• Ensure that the processes are compliant with Quality System and EHS requirements
• Other such duties that may be determined by Management

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.

Position Requirements:

• Ability to apply experience in meeting requirement of FDA Quality System Regulations and/ or ISO 13485 Standard
• Experience in applying appropriate quality tools
• Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools
• May have experience with electronic documentation system (TeamCenter - Siemens), enterprise resource planning tools (SAP) and etc
• Must be detailed oriented, well organized and able to work independently and in teams
• Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work

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

Preferred Experience/Education/Skills:

• Bachelor\xe2\x80\x99s degree in Engineering or Biological/Life Sciences
• More than 3 years of working experience in manufacturing and laboratory environment
• Experience in supporting manufacturing operations, or QC/QA operations
• Have good pipetting skills and experience in analytical testing is preferred
• Have experience in Laboratory Information Management System (LIMS) is preferred for traceability, chain of custody for QC test samples and data analysis
• Good understanding of FDA regulatory environment (CFR 820), 510k and ISO 13485 strongly preferred
• Experience in medical device/ pharmaceutical/ IVD is preferred

Illumina believes that everyone has the ability to make an impact, and 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.

Illumina