Senior Quality Specialist

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. Responsibilities: * Manage the document control program as well as suggest and implement improvements to existing processes. * Analyze and process Change Requests (CRs) and Change Orders (COs) in Ensur. * Write, edit, review, and maintain procedural documentation including, but not limited to, department policies, procedures, and guidance documentation at Illumina Laboratory Services (ILS). * Perform document processing, distribution of controlled copies, and filing using manual and electronic systems per established procedures. * Monitor change activities approval/implementation and resolve issues of varying complexity. * Facilitate record management, including maintenance for retention periods. Ensure compliance with appropriate regulations. * Onboard/offboard employees in the Ensur system. * Provide training for the Ensur system, Quality Systems New Hire Orientation, and Document Controls process, as needed. * Maintain personnel records in the system. * Assign document training as per management request based on the department training matrix/training plan. * Create and maintain training matrices for the organization with collaboration from management. * Support tracking, trending, and reporting of document training. * Communicate and conduct training as needed for users. * Manage or support the training program as well as suggest and implement improvements to existing processes. * Support the tracking and review of competency assessments and the training records review process. * Provide Ensur system administration support throughout the organization, resolving issues, answering questions, and fulfilling custom requests. * Support the administration and validation of upgrades of the Ensur System. * Work with the software provider (DocXellent) to resolve issues, for custom requests, and to coordinate software updates/upgrades. * Interface with internal and external customers to convey requirements and resolve issues to drive efficient and effective processes. * Prioritize and coordinate tasks and projects within a fast-paced environment. * Ensure standard practices and procedures are followed when analyzing data and content. * Escalate issues and risks to management, as appropriate. * Monitor documentation system performance. Generate Quality Indices and feedback for continuous improvement. * Drive best practices throughout the organization. * Perform trending analysis (Quality Metrics) on an as-needed basis, including using statistical process control methods. * Participate in internal and external audits, nonconformity investigations, and CAPA investigations, as needed. * Work with management to improve quality system policies and procedures. * Participate in global projects supporting all 3 sites, as needed. * Assist in internal and external audits, as needed. * Collaborate deeply with cross functional teams to implement new processes and promote awareness and adherence to policy and procedures * May include other duties as defined by the department Manager. 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: * Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience * B.S. Degree in Molecular Biology or related field plus 5 years of industry experience; in vitro diagnostic or molecular reagent quality assurance is preferred * 5-8 years of direct work experience in QA, including all aspects of device/diagnostic quality systems * Experience understanding and applying quality system regulations and standards, including GDP, FDA, CLIA, CAP, NYSDH, ISO 13485 and/or CFR Part 820 and Part 11 is a plus * Excellent problem solving and analytical skills. * Effective interpersonal and communication skills and capable of supporting cross-functional project goals. * Experience in MS Word, Excel, Lucid charts and PowerPoint required to conduct data analysis/ data trending and assist in developing process maps and procedures * Quality engineering experience is a plus. * Must be team oriented and have effective communication skills to work as part of a team All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.