LIMS Administrator

Location: Seattle – Fully onsite

Position Summary:

In this role you will manage and maintain our Laboratory Information Management System (LIMS). The ideal candidate will have a strong background in LIMS administration within a regulated environment, preferably within the pharmaceutical industry. This role is critical to ensuring the efficient operation of our laboratory and the integrity of our data. The LIMS Administrator will play a key role in system maintenance, user support, data management, and continuous improvement initiatives related to the LIMS.

Responsibilities:

1. System Administration: Perform daily administration of the LIMS, including user management, security settings, data backups, and system upgrades.
2. Troubleshooting and Support: Provide technical support to LIMS users, troubleshoot system issues, and resolve user inquiries.
3. Data Management: Ensure data integrity and accuracy within the LIMS. Develop and implement data management procedures, including data entry, validation, and reporting.
4. System Enhancement: Identify opportunities for system improvement and automation. Collaborate with IT and laboratory personnel to implement enhancements and new functionalities.
5. Validation and Compliance: Maintain system validation documentation and ensure compliance with relevant regulatory requirements, including 21 CFR Part 11, EU Annex 11, and ISO 9001 standards.
6. Training: Develop and deliver training materials for LIMS users.
7. Vendor Management: Liaise with LIMS vendors for technical support, system upgrades, and maintenance contracts.
8. Documentation: Maintain comprehensive system documentation, including SOPs, validation protocols, and training materials.

Requirements:

1. 8+ years of demonstrated experience in administering a LIMS within a regulated laboratory environment.
2. Proven experience with vendor selection, system implementation, and system integration projects for LIMS.
3. Prior experience in a pharmaceutical Quality Assurance role is required. ASQ CQA, CMQ/OE, or other relevant certifications are a plus.
4. Experience with 21 CFR Part 11, EU Annex 11, and ISO 9001 quality management system standards.
5. Documentation and Records Management experience, ideally in a laboratory setting.