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Technical Expert eLIMS CoE QC Operations

Johnson & Johnson
USA
Full-time
Mid · 2+ years experience
Hybrid
Discovered 2 weeks ago
eLIMSLabVantageEDMSCOMETTableauPower Automate

Full Job Posting

Position Summary

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.

Accountabilities:

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

Ensures accuracy, completeness, and compliance of master data within eLIMS

Essential Job Duties and Responsibilities

  • Master Data Management (50-60%)
  • 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)
  • 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
  • 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
  • Quality Systems & Compliance (20-30%)
  • 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
  • Evaluate change requests for system and cross-functional impact
  • Act as Change Control Executor: Implement approved changes within eLIMS and related systems
  • Implement approved changes within eLIMS and related systems
  • Participate in: Pre-CoC / kick-off discussions Planning and execution of change implementations
  • Pre-CoC / kick-off discussions
  • Planning and execution of change implementations
  • Ensure compliance with: Internal procedures (SOPs, WIs) Regulatory requirements (cGMP, GxP)
  • Internal procedures (SOPs, WIs)
  • Regulatory requirements (cGMP, GxP)
  • Maintain and update system-related documentation in EDMS, ensuring: Accuracy Traceability Version control compliance
  • Accuracy
  • Traceability
  • Version control compliance
  • Project Support & Continuous Improvement (15-20%)
  • Support and contribute to system-related projects, including: System upgrades Enhancements New implementations (e.g., iLABs, NPIs)
  • 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)
  • Data Management & Reporting (up to 10%)
  • Utilize approved analytical tools (e.g., Tableau, Power Automate) for: Data extraction Reporting Automation and process efficiency improvements
  • Data extraction
  • Reporting
  • Automation and process efficiency improvements
  • Support data-driven decision-making and process monitoring

Scope & Interfaces

Complex eLIMS (LabVantage) master data configuration and governance

Multi-site QC environments

Cross-functional and global operations

Key Interfaces

QC Operations / Laboratory teams (multi-site)

Quality Assurance / Quality Systems

eLIMS CoE / System Owners

IT / Digital / Automation teams

Cross-functional stakeholders (e.g., Manufacturing, Supply Chain)

Required

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

cGMP / GxP requirements

Quality systems and compliance processes

Risk management principles

Demonstrated ability to: Manage complex topics independently Prioritize and organize effectively Escalate appropriately

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

Preferred

Advanced experience in eLIMS master data configuration (multiple data types)

Strong understanding of: iLABs / paperless lab processes New Product Introduction (NPI) workflows

iLABs / paperless lab processes

New Product Introduction (NPI) workflows

Experience with: Stability Master Data Management COA configuration

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)

Core Competencies

Advanced analytical thinking

High attention to detail

Structured problem-solving

Strong ownership and accountability

Stakeholder influence and collaboration

Ability to manage complexity in regulated environments

At 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.

Here’s what you can expect

Application review: We’ll carefully review your CV to see how your skills and experience align with the role.

Getting 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.

Staying 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.

Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally, 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

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