Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

Collaborate cross functionally with various areas of the organizations to develop a deep understanding of how our Laboratory Information Management System (LIMS) is enabling digital execution of Quality Labs operations. The Business Analyst will solve business challenges and/or maximize opportunities, while understanding business needs, requirements, and current processes. 

How you'll make an impact:

• LIMS Expertise:  Utilize in-depth knowledge of LIMS modules such as, Electronic Laboratory Notebook (ELN), Environmental Monitoring (EM), Sample Management, Instrument Interface, Results Entry, Inventory
• Quality Labs Expertise: Has a deep understanding of the lab processes such as sample management, test execution/documentation, results review, product release/metrics, and instrument data acquisition across multiple labs (Chemistry, Microbiology, Biology). 
• Management, and Reporting tools to streamline laboratory processes, manage data, and ensure compliance with industry standards.
• Requirement Analysis and Management: Able to assess business needs, including the business case for system enhancement requests.
• Collaboration: Seek to understand the data and digital process needs of our stakeholders. Work closely with the lab managers, IT, Software Quality and Business Process Owners to manage the progress of system enhancement execution. 
• Process Improvement:  Identify opportunities for process improvement and automation within the laboratory, leveraging LIMS functionalities to enhance efficiency and accuracy.
• User Training:  develop and deliver user training programs for laboratory staff to ensure they can effectively utilize the LIMS system, and provide ongoing support and troubleshooting.
• Change Management:  Manage change control process relating to LIMS system changes, assess the impact of changes, and communicate effectively with stakeholders.
• Document technical design and requirement definition documents that will be used to implement system features and reports.
• Ability to learn and map lab processes and technology usage in different quality labs across the organization, documenting results in lab workflows.
• Evaluate and analyze moderately complex technical information and data related to quality indicators, identifying trends and driving factors and recommending course corrections. Draft presentations and present summaries of trends, potential root causes, and recommended course corrections
• SME point of contact for the local lab operations team, supporting resolution of processing bottlenecks

What you'll need (Required): Education and experience requirements

• Bachelor's Degree in related field, 5 years's experience
• Experience working in a medical device and/or regulated industry Preferred
• Experience with electronic LIMS Systems (Labware, LabVantage, Agilent etc.)
• Knowledge and experience with Quality Systems 
• Good written and verbal English communication skills

What else we look for (Preferred): Relevant skills
• Good project management skills (e.g., documenting data flows, business processes, power point presentations)
• Proven expertise in both Microsoft Office Suite, including advanced tools and systems
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability speak to varying levels across the organization and drive achievement of objectives
• Ability to learn new concepts and software quickly
• Analytical approach to problem-solving; ability to use technology to solve business problems
• Familiarity with database-centric applications
• Knowledge of Master Data Management including Domain / Entity Definition, Golden Records / Single Source of Truth. Data Enrichment, Data Matching / Duplication