Lead, LIMS Administrator
Work schedulePermanent, full time
Start dateAs soon as possible
With unrivaled expertise in immunology, and operating sites in North America (East and West Coast) and Europe, Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious diseases, metabolic diseases, and oncology fields. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines, anti-viral drugs, and immunotherapy, gene and cell therapy products.
We are currently seeking a highly motivated candidate with very strong LIMS experience to fill the position of LIMS Administrator for the Seattle Nexelis site. This position reports to the VP Data Management & IT and requires strong experience at implementing and maintaining a Laboratory Information Management System (LIMS) in the pharma industry. The primary role is to provide LIMS administration expertise to collaborate in the LIMS upgrade project and fill the role of local LIMS administrator for the LabVantage LIMS while ensuring compliance with internal procedures and industry guidelines (e.g. 21-CRF-11, GAMP, NIST, GCLP, GLP).
- Local LIMS administrator for the Seattle Nexelis site. Participate in the implementation of the LabVantage LIMS system and related applications/instruments;
- Diagnose issues, troubleshoot, and collaborate with Lab Vantage project team and Nexelis support teams (LIMS, Validation, IT, QA) to resolve issues;
- Ensure LIMS maintenance, improvements, and corrective modifications in collaboration with Lab Vantage, Nexelis support teams and local Laboratory Operations staff to optimize operational efficiency;
- Update the Laboratory Information Management System (LIMS) with the required Master Data, Tests and Studies as defined in the project functional specification. Manage system security and manage user access requests, modifications, and withdrawals;
- Train users on LIMS, maintain and update training materials and provide technical support. Ensure required Standard Operating Procedures are in place and up to date for the LIMS;
- Primary subject matter expert (SME) for LIMS during audits, will ensure the audit readiness of the following: qualification documentation, user lists and privileges, and procedures;
- Ensure LIMS activities are conducted in compliance with current Good Laboratory Practices (GLP), all data integrity standards are maintained, and issues are mitigated in a timely manner;
- Authoring lead for LIMS and LIMS related application validation projects;
- Collaborate on validation authoring/review of various equipment/computerized system validation projects;
- Coordinate change controls for modifications to validated equipment/computerized systems.
Experience and Qualifications
- Minimum of 7 years’ experience using LIMS systems in a regulated lab (GLP or GMP);
- Minimum 3 years’ experience as a LIMS System Administrator;
- Experience with LabVantage LIMS highly desirable;
- Knowledge of basic SQL queries would be an asset;
- Excellent teamwork, service oriented and organizational skills;
- Very strong English writing and communication skills;
- Ability to work methodically with precision, accuracy, and quality;
- Strong working experience with LIMS in regulated pharma environments (GLP or GMP); preferably with Lab Vantage;
- Proficient with MS office tools (e.g. Word, Excel, Outlook).
B.Sc. in life sciences, chemistry, computer science, engineering or related