LIMS Administrator

LIMS Administrator

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:

• System Administration: Perform daily administration of the LIMS, including user management, security settings, data backups, and system upgrades.
• Troubleshooting and Support: Provide technical support to LIMS users, troubleshoot system issues, and resolve user inquiries.
• Data Management: Ensure data integrity and accuracy within the LIMS. Develop and implement data management procedures, including data entry, validation, and reporting.
• System Enhancement: Identify opportunities for system improvement and automation. Collaborate with IT and laboratory personnel to implement enhancements and new functionalities.
• 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.
• Training: Develop and deliver training materials for LIMS users.
• Vendor Management: Liaise with LIMS vendors for technical support, system upgrades, and maintenance contracts.
• Documentation: Maintain comprehensive system documentation, including SOPs, validation protocols, and training materials.

Requirements:

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