ELN Administrator

Duties and Responsibilities

• Design, build, and maintain ELN templates for ligand binding assays, including PK, immunogenicity (ADA), and biomarker workflows.
• Design, build, and maintain ELN templates for Critical Reagent workflows.
• Maintain version control and lifecycle management of ELN templates.
• Serve as a Subject Matter Expert (SME) for ELN Template generation, qualification, and implementation within a regulatory environment.
• Ensure all ELN templates comply with GLP, GCP, and 21 CFR Part 11 requirements for electronic records and signatures.
• Partner with Quality Assurance (QA) to ensure templates meet audit and inspection readiness standards.
• Incorporate data integrity principles (ALCOA+) into all template designs.
• Support audit preparation and responses related to ELN processes.
• Work closely with various B2S team members to understand workflow requirements.
• Collaborate with IT and ELN system administrators (internally & externally) to implement template functionality and updates.
• Identify opportunities to improve template usability, automation, and efficiency.
• Drive standardization across assays, studies, and clients where appropriate.
• Contribute to SOP development and best practices for ELN usage.
• Provide guidance and support to laboratory staff on ELN template usage, training, and deployment.
• Assist in troubleshooting template-related issues.
• Develop training materials and conduct user training sessions as needed.

Regulatory Compliance & Data Integrity

• Ensure all ELN templates comply with GLP, GCP, and 21 CFR Part 11 requirements for electronic records and signatures.
• Partner with Quality Assurance (QA) to ensure templates meet audit and inspection readiness standards.
• Incorporate data integrity principles (ALCOA+) into all template designs.

Cross-Functional Collaboration

• Work closely with various B2S team members to understand workflow requirements.
• Collaborate with IT and ELN system administrators (internally & externally) to implement template functionality and updates.

Process Improvement & Standardization

• Identify opportunities to improve template usability, automation, and efficiency.
• Drive standardization across assays, studies, and clients where appropriate.
• Contribute to SOP development and best practices for ELN usage.

User Support & Training

• Provide guidance and support to laboratory staff on ELN template usage, training, and deployment.
• Assist in troubleshooting template-related issues.
• Develop training materials and conduct user training sessions as needed.

Documentation & Change Management

• Manage template change requests and document all updates in accordance with change control procedures.
• Maintain clear documentation of template specifications and configurations.