LIMS Administrator
1872 Consulting
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:
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.
- 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
Vacancy posted 2 days ago
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