Local Analytical Definition Specialist
Core
Translate analytical methods, specifications, and stability protocols into configured templates within a Laboratory Information Management System (LIMS) to support accurate laboratory testing for BioPharmaceutical and Medical Device clients.
Role type
Analytical Definition Specialist (LIMS Configuration)
Builds
Configured analytical definition templates in LIMS
Domain
Life Sciences / BioPharmaceutical / Medical Device
Required skills
LIMS configuration, analytical methodology, specifications, certificates of analysis, stability protocols, GMP/GLP compliance, process documentation, quality review
Preferred skills
Laboratory operations, project management, process improvement
Technologies
Laboratory Information Management Systems (LIMS)
Responsibilities
Build and maintain analytical definition templates in LIMS; Partner with stakeholders to clarify requirements and determine template configurations; Perform detailed reviews to ensure builds match requests and are error-free; Prioritize work based on deadlines and client needs; Maintain knowledge of systems, procedures, and regulatory requirements.
Seniority
Individual Contributor