Technical Expert eLIMS CoE QC Operations

Johnson & Johnson Innovative Medicine•Horsham, PA

1d•Hybrid

About The Position

The Analyst eLIMS CoE, QC Operations, is responsible for the independent configuration, governance, and lifecycle management of complex master data within the eLIMS (LabVantage) system. The 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. The 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. The Analyst will escalate issues whenever required and understand the impact towards our customers when changing / updating existing Master Data.

Requirements

Bachelor’s degree or equivalent combination of education and experience
2–4 years of experience in a regulated environment
Hands-on experience with eLIMS (LabVantage)
Solid knowledge of: cGMP / GxP requirements, Quality systems and compliance processes, Risk management principles
Demonstrated ability to: Manage complex topics independently, Prioritize and organize effectively, Escalate appropriately
Strong communication skills in English (minimum B2; C1 preferred)
Proven ability to work independently and lead domain-specific initiatives
Strong stakeholder management and cross-functional collaboration skills

Nice To Haves

Advanced experience in eLIMS master data configuration (multiple data types)
Strong understanding of: iLABs / paperless lab processes, New Product Introduction (NPI) workflows
Experience with: Stability Master Data Management, COA configuration
Proficiency in Enterprise Quality Systems (e.g., COMET)
Experience in Change Control (assessment and execution ownership)
Experience with EDMS (e.g., TruVault)
Understanding of multi-site configurations (Biotherapeutics, Synthetics, Advanced Therapies)

Responsibilities

Ensures accuracy, completeness, and compliance of complex master data within eLIMS
Drives harmonized and standardized system configurations across sites and processes
Leads and executes change control activities, including impact assessments and implementation
Maintains inspection-ready documentation across systems (eLIMS, EDMS, etc.)
Acts as subject matter expert (SME) for assigned domains (e.g., Release, Stability)
Identifies and drives process improvements and optimization initiatives
Ensures timely and coordinated resolution of complex issues across multiple stakeholders
Independently create, review, approve, and maintain complex master data in eLIMS (LabVantage)
Configure and maintain master data related to: Release processes, Stability studies, Raw Materials (RM), Packaging Materials (PM), Certificate of Analysis (COA)
Ensure all configurations meet defined data standards and design structures, are accurate, complete, and compliant
Manage and coordinate master data requests across multiple sites within Base Business operations
Support and maintain Stability Master Data Management across sites, where applicable
Support maintenance of Common Specifications and cross-site harmonization
Translate complex business requirements into system configurations
Apply advanced understanding of paperless laboratory processes and master data design files
Support Non-Conformance (NC) and Correctiva Action / Preventive Action (CAPA) processes within the Enterprise Quality Management System (e.g., COMET)
Act as Change Control Assessor: Evaluate change requests for system and cross-functional impact
Act as Change Control Executor: Implement approved changes within eLIMS and related systems
Participate in: Pre-CoC / kick-off discussions, Planning and execution of change implementations
Ensure compliance with: Internal procedures (SOPs, WIs), Regulatory requirements (cGMP, GxP)
Maintain and update system-related documentation in EDMS, ensuring: Accuracy, Traceability, Version control compliance
Support and contribute to system-related projects, including: System upgrades, Enhancements, New implementations (e.g., iLABs, NPIs)
Perform and/or support User Acceptance Testing (UAT) activities
Act as interface between iLABs Base Business / project teams and automation initiatives
Identify inefficiencies and drive process improvements
Propose and implement optimization initiatives within master data and system processes
May act as Process Owner (PO) for defined processes (e.g., Release, Stability)
Utilize approved analytical tools (e.g., Tableau, Power Automate) for: Data extraction, Reporting, Automation and process efficiency improvements
Support data-driven decision-making and process monitoring