Descripción de la oferta
Mantell Associates is currently supporting a global biopharmaceutical organisation based in León, specialising in the development, manufacturing, and commercialisation of biosimilars, alongside offering integrated CDMO services worldwide.With continued investment driving growth, they are looking to expand their Quality Control team with an experienced QC Consultant specialising in biological methods. This is a fully onsite role within a GMP-regulated laboratory environment.QC Consultant - Responsibilities:Perform biological and immunochemical testing (e.G. potency assays, bioassays, ELISA) in line with GMP requirementsSupport method validation, transfer, and lifecycle management of analytical methodsLead and manage deviations, OOS and OOT investigations, including root cause analysis and CAPA implementationPrepare and review validation protocols, reports, and technical documentationSupport stability studies and characterisation of reference materialsManage QC documentation, including SOPs, specifications, and change controlsContribute to laboratory organisation and coordination within the potency & contaminants teamQC Consultant - Requirements:Strong experience in biological QC / bioassays / potency testingHands-on expertise with ELISA, cell-based assays, or immunoassaysProven experience in GMP environmentsSolid background in method validation and investigations (OOS/OOT)Fluent Spanish and good level of EnglishMinimum 3+ years' experience in a similar QC roleWhat's on Offer:Opportunity to join a high-growth, investment-backed CDMOExposure to advanced biopharmaceutical products (biosimilars)Collaborative, project-driven environment with strong pipelineCompetitive daily rate, reflective of the technical expertise requiredMantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0) .
