Technical Expert eLIMS CoE QC Operations

• 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

• 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)

Analytical 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

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

• 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)
• 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
• 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
• 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
• Project Support & Continuous Improvement (15-20%)
• 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)
• Data Management & Reporting (up to 10%)
• 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

Quality

Quality Systems

Professional

Horsham, 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

• Complex eLIMS (LabVantage) master data configuration and governance
• Multi-site QC environments
• Cross-functional and global operations

• 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)

• 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
• undefined