Analyst eLIMS CoE QC Operations
$44,700–$70,840 year
HybridRaritan, New Jersey, United States or Horsham, Pennsylvania, United States
Job Summary
Create, review, approve, and maintain complex master data in the eLIMS (LabVantage) system to ensure accuracy, completeness, and compliance within a GxP environment. Configure master data supporting Release, Stability, Raw Materials, Packaging Materials, and COA-related processes while translating laboratory requirements into effective system configurations. Execute change control activities, including impact assessments and implementation planning, and support User Acceptance Testing, system upgrades, and new implementations. Collaborate with laboratories, quality organizations, and cross-functional partners to enable efficient paperless laboratory processes and drive continuous improvement initiatives across a global network.
Required Qualifications
- Bachelor's degree or equivalent combination of education and experience
- 2 to 4 years of experience in a regulated environment
- Hands-on experience with eLIMS / LabVantage
- Solid knowledge of cGMP / GxP requirements, quality systems, compliance processes, and risk management principles
- Demonstrated ability to manage complex topics independently, prioritize effectively, and escalate appropriately
- Strong communication skills in English, minimum B2 level
- Strong stakeholder management and cross-functional collaboration skills
- Ability to work independently and lead domain-specific initiatives
- 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
Desired Qualifications
- Advanced experience in eLIMS master data configuration across multiple data types
- Strong understanding of iLABs / paperless laboratory processes and New Product Introduction workflows
- Experience with Stability Master Data Management and COA configuration
- Experience with Enterprise Quality Systems such as COMET
- Experience in change control assessment and execution ownership
- Experience with EDMS solutions, for example TruVault
- Previous Johnson & Johnson experience
- Experience in the pharmaceutical industry
- Understanding of multi-site configurations across Biotherapeutics, Synthetics, and Advanced Therapeutics
- C1 level English communication skills
- High attention to detail
- Structured problem-solving
- Strong ownership and accountability
- Stakeholder influence and collaboration
- Ability to manage complexity in regulated environments
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