Quality Control Associate - LIMS
Job Description
• Hands-on experience in LIMS master creation, revision, and review support
• Knowledge of specifications, sample plans, test methods, calculations, inventory, schedules, reagent masters, and stability masters.
• Understanding of LIMS workflow configuration, approval workflows, and audit trail requirements.
• Experience in challenge testing and verification of configured masters against approved source documents
• Understanding of QC analytical, microbiology, stability, raw material, packing material, and bioassay testing processes.
• Familiarity with specifications, STPs, methods, protocols, and laboratory workflows.
• Knowledge of analytical techniques such as HPLC, UPLC, TOC, BET, CE-SDS, HCD, HCP, particle count, and environmental monitoring
• Ability to interpret SOPs, Work Instructions, Specifications, Forms, Validation Reports, Qualification Protocols, and JOS documents.
• Understanding of change controls, deviations, CAPAs, OOT/OOS requirements, and audit trail review expectations.
Requirements
Function: Other
Experience Level: Mid-Senior Level