1872 Consulting
LIMS Administrator
1872 Consulting - Airway Heights, Washington, United States, 99001
Work at 1872 Consulting
Overview
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Overview
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:
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.
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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:
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.
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