Sr. Quality Operation Analyst

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.

Summary:                       Supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for company products, services and processes. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.

Responsibilities:   Applies core knowledge and understanding of area of specialization to provide solutions in creative and effective ways. Assesses unusual circumstances and uses sophisticated analytical and problem-solving techniques to identify cause and suggest variations in approach. Works on assignments of diverse scope where information is limited and problem solving requires adaptation of existing techniques. Enhances internal and external working relationships and networks with senior partners within area of expertise. Adapts style to differing audiences and often advises others on difficult matters that require persuasion. Work is done independently and is reviewed at critical points. Uses evaluation, judgment, and interpretation to select best course of action. 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.

Requirements:   Knowledge and practical experience of laws and QMS ministerial requirements. Proactive approach / able to appropriately demonstrate unique initiatives Business level English verbal communication skills and writings, especially Quality operation documentation and writings. Negotiation with internal / external stakeholders in difficult case Experience for IFU and/or Safety notification letter updates Native level Japanese verbal communication skills and writings. Basic PC Skills (Microsoft Excel, Word, PowerPoint, Access, Outlook) Minimum 5 year’s work experience in Drug, Medical Device, and/or In Vitro Diagnostics industries. Minimum 3 year’s work experience in Quality Control and/or Quality Assurance Organization under the Drug, Medical Device, and/or In Vitro Diagnostics industries. Work at 1st Class Medical Device MAH or equivalent, and/or IVD MAH Experience for acting as Quality Controller in 1st Class Medical Device MAH Experience for recall action under PMD Act Experience for Foreign Manufacturing site management     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:   Pharmacist license In Vitro Diagnostic reagent handling experience Electrical Instruments, Software as Medical Device experience Experience for Quality Controller (Kokunai Hinshitsu Sokatu Sekininsha) Experience for QMS Audit Experience (Internal/External) Experience for QMS