Analyst at Edwards Lifesciences Corp in Irvine, CA

📌 Irvine 🏷️ Other 🕑 2021-06-23
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Laboratory IT Business System Analyst

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. For more than 50 years, we have established a remarkable track record around that innovation: Work that enables clinicians around the world to enhance and save lives. Edwards is looking for a Laboratory Information Technology (LIT) Business Systems Analyst (BSA). In this role, you will play a critical role in our ability to deliver devices that maximize our patient's recovery and quality of life by owning responsibility for the implementation and support of the LabWare Lab Information Management System (LIMS) globally across the Edwards Quality Labs. You will be the subject matter expert supporting laboratory technology solutions, and a domain expert of laboratory technologies, applications, and solutions to improve business processes by leveraging their foundational laboratory and IT knowledge. The BSA will enable laboratory personnel and super-users to leverage LIMS for business process automation and optimization through training and knowledge transfer. This position is also expected to support general laboratory informatics needs. Key

Responsibilities

Perform LIMS system setup and configuration, manage and maintain LIMS static data Gather and document functional requirements specifications that will be used to implement LIMS features and reports Test new LIMS features, integration, and reports, and coordinate user acceptance testing Develop IQ/OQ/PQ test scripts to support validation of new functionality and coordinate validation activities. Provide diagnosis and timely resolution of LIMS issues to support business users including root cause analysis and defect resolution Create training material and deliver user training Support lab users and vendors with analytical equipment qualification and validation to ensure data integrity per the relevant standards (21 CFR Part 11) Develop and maintain standard operating procedures, work instructions, detailed diagrams of business processes, data mapping, as well as the supporting applications, and interfaces Configure and test validated IT systems to execute features, integration, and reporting per Software Development Lifecycle (SDLC) including the authoring of requirement documents, specification documents, and test scripts Participate in business systems analysis services (analyze, define, troubleshoot, design, test, deliver, maintain) with assistance from LIT team members Manage small sized projects / enhancements and collaborate with project leads to determine how requirements will be approached and managed for a particular project Work with senior LIT team members to create clear and unambiguous requirements, work plans, identify task dependencies, and support risk and change management activities Execute the test strategy and test plans and ensure they adequately cover the requirements

Basic Qualifications

Bachelor's degree in Computer Science or in a laboratory science (Chemistry, Biology, Microbiology) 2+ years' experience in a Business Systems Analyst or System Analyst role; or 2+ years' experience supporting lab applications Working knowledge of laboratory systems such as LabWare LIMS 1+ years' experience as a LabWare LIMS administrator 1+ years of FDA industry experience (e.g. medical device, pharmaceuticals, etc.); or in highly regulated environments Prior experience working in global business environment with multi-language requirements Proficient in Microsoft Office Suite (i.e. Share.
Point, Outlook, Visio, Excel, PPT, Word) Ability to interpret and define business user requirements into detailed specifications Strong ability to manage and work in a multi-cultural environment Strong analytical and logical problem-solving skills, root cause analysis Strong interpersonal, written, and verbal communication skills - able to interact with business stakeholders Possess and display sound judgment, initiative, flexibility, and detail-orientation Ability to develop and maintain business and technical documentation Organizational and project management skills a plus

Preferred Qualifications

LabWare LIMS Administration or ELN certification Prior experience in working with Quality Lab Departments Previous experience with laboratory equipment systems such ELN, Chemstation, OpenLab, Charles River, WinKQCL, Provantis, etc. Experience with FDA guidelines for Software Quality and Systems Validation Experience with Good Laboratory, Good Documentation Practices, and other GxP processes Experience in Med Device or Pharma industry Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

View Application

You will be redirected to Edwards Lifesciences Corp's preferred application process.

You will be redirected to Edwards Lifesciences Corp's preferred application process.

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