Technical Expert eLIMS CoE QC Operations

pAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. /p pAs guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /p h3Job Function /h3 pQuality /p h3Job Sub Function /h3 pQuality Systems /p h3Job Category /h3 pProfessional /p h3All Job Posting Locations /h3 pHorsham, Pennsylvania, United States of America, Leiden, South Holland, Netherlands, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland /p h3Job Description /h3 h3Position Summary /h3 pThe Analyst eLIMS CoE, QC Operations, is responsible for the independent configuration, governance, and lifecycle management of complex master data within the eLIMS (LabVantage) system. /p pThe role ensures that system configurations are accurate, compliant, and aligned with business and regulatory requirements. The position applies advanced system and process knowledge to translate complex requirements into effective configurations and supports the continuous improvement of QC laboratory operations within a regulated (GxP) environment. /p pThe Analyst operates with a high degree of autonomy, takes ownership of assigned domains, and acts as a subject matter expert (SME) for site-specific and cross-functional processes. /p pThe Analyst will escape issues whenever required and understand the impact towards our customers when changing / updating existing Master Data. /p h3Accountabilities /h3 ul liEnsures accuracy, completeness, and compliance of complex master data within eLIMS /li liDrives harmonized and standardized system configurations across sites and processes /li liLeads and executes change control activities, including impact assessments and implementation /li liMaintains inspection-ready documentation across systems (eLIMS, EDMS, etc.) /li liActs as subject matter expert (SME) for assigned domains (e.g., Release, Stability) /li liIdentifies and drives process improvements and optimization initiatives /li liEnsures timely and coordinated resolution of complex issues across multiple stakeholders /li liEnsures accuracy, completeness, and compliance of master data within eLIMS /li /ul h3Essential Job Duties And Responsibilities /h3 ul liMaster Data Management (50-60%) /li liIndependently create, review, approve, and maintain complex master data in eLIMS (LabVantage) /li liConfigure and maintain master data related to: ul liRelease processes /li liStability studies /li liRaw Materials (RM) /li liPackaging Materials (PM) /li liCertificate of Analysis (COA) /li /ul /li liEnsure all configurations: ul liMeet defined data standards and design structures /li liAre accurate, complete, and compliant /li /ul /li liManage and coordinate master data requests across multiple sites within Base Business operations /li liSupport and maintain Stability Master Data Management across sites, where applicable /li liSupport maintenance of Common Specifications and cross-site harmonization /li liTranslate complex business requirements into system configurations /li liApply advanced understanding of paperless laboratory processes and master data design files /li /ul ul liQuality Systems Compliance (20-30%) /li liSupport Non-Conformance (NC) and Correctiva Action / Preventive Action (CAPA) processes within the Enterprise Quality Management System (e.g., COMET) /li liAct as Change Control Assessor: ul liEvaluate change requests for system and cross-functional impact /li /ul /li liAct as Change Control Executor: ul liImplement approved changes within eLIMS and related systems /li /ul /li liParticipate in: ul liPre-CoC / kick-off discussions /li liPlanning and execution of change implementations /li /ul /li liEnsure compliance with: ul liInternal procedures (SOPs, WIs) /li liRegulatory requirements (cGMP, GxP) /li /ul /li liMaintain and update system-related documentation in EDMS, ensuring: ul liAccuracy /li liTraceability /li liVersion control compliance /li /ul /li /ul ul liProject Support Continuous Improvement (15-20%) /li liSupport and contribute to system-related projects, including: ul liSystem upgrades /li liEnhancements /li liNew implementations (e.g., iLABs, NPIs) /li /ul /li liPerform and/or support User Acceptance Testing (UAT) activities /li liAct as interface between iLABs Base Business / project teams and automation initiatives /li liIdentify inefficiencies and drive process improvements /li liPropose and implement optimization initiatives within master data and system processes /li liMay act as Process Owner (PO) for defined processes (e.g., Release, Stability) /li /ul ul liData Management Reporting (up to 10%) /li liUtilize approved analytical tools (e.g., Tableau, Power Automate) for: ul liData extraction /li liReporting /li liAutomation and process efficiency improvements /li /ul /li liSupport data-driven decision-making and process monitoring /li /ul h3Scope Interfaces /h3 ul liComplex eLIMS (LabVantage) master data configuration and governance /li liMulti-site QC environments /li liCross-functional and global operations /li /ul h3Key Interfaces /h3 ul liQC Operations / Laboratory teams (multi-site) /li liQuality Assurance / Quality Systems /li lieLIMS CoE / System Owners /li liIT / Digital / Automation teams /li liCross-functional stakeholders (e.g., Manufacturing, Supply Chain) /li /ul h3Minimum Qualification /h3 h3Required /h3 ul liBachelor’s degree or equivalent combination of education and experience /li li2-4 years of experience in a regulated environment /li liHands-on experience with eLIMS (LabVantage) /li liSolid knowledge of: ul licGMP / GxP requirements /li liQuality systems and compliance processes /li liRisk management principles /li /ul /li liDemonstrated ability to: ul liManage complex topics independently /li liPrioritize and organize effectively /li liEscalate appropriately /li /ul /li liStrong communication skills in English (minimum B2; C1 preferred) /li liProven ability to work independently and lead domain-specific initiatives /li liStrong stakeholder management and cross-functional collaboration skills /li /ul h3Preferred /h3 h3Other requirements /h3 ul liAdvanced experience in eLIMS master data configuration (multiple data types) /li liStrong understanding of: ul liiLABs / paperless lab processes /li liNew Product Introduction (NPI) workflows /li /ul /li liExperience with: ul liStability Master Data Management /li liCOA configuration /li /ul /li liProficiency in Enterprise Quality Systems (e.g., COMET) /li liExperience in Change Control (assessment and execution ownership)Experience with EDMS (e.g., TruVault) /li liUnderstanding of multi-site configurations (Biotherapeutics, Synthetics, Advanced Therapies) /li /ul h3Core Competencies /h3 ul liAdvanced analytical thinking /li liHigh attention to detail /li liStructured problem-solving /li liStrong ownership and accountability /li liStakeholder influence and collaboration /li liAbility to manage complexity in regulated environments /li liundefined /li /ul pAt Johnson Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time. /p h3Here’s What You Can Expect /h3 ul liApplication review: We’ll carefully review your CV to see how your skills and experience align with the role. /li liGetting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have. /li liStaying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step. /li liFinal steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these. /li /ul pFinally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA /p h3Required Skills /h3 h3Preferred Skills /h3 pAnalytical Reasoning, Business Alignment, Business Behavior, Collaboration, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Execution Focus, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People /p #J-18808-Ljbffr