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.
Obtenga más información sobre las tareas generales relacionadas con esta oportunidad a continuación, así como sobre las habilidades requeridas.
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 requirements
* Support method validation, transfer, and lifecycle management of analytical methods
* Lead and manage deviations, OOS and OOT investigations, including root cause analysis and CAPA implementation
* Prepare and review validation protocols, reports, and technical documentation
* Support stability studies and characterisation of reference materials
* Manage QC documentation, including SOPs, specifications, and change controls
* Contribute to laboratory organisation and coordination within the potency & contaminants team
QC Consultant - Requirements:
* Strong experience in biological QC / bioassays / potency testing
* Hands-on expertise with ELISA, cell-based assays, or immunoassays
* Proven experience in GMP environments
* Solid background in method validation and investigations (OOS/OOT)
* Fluent Spanish and good level of English
* Minimum xsgfvud 3+ years' experience in a similar QC role
What's on Offer:
* Opportunity to join a high-growth, investment-backed CDMO
* Exposure to advanced biopharmaceutical products (biosimilars)
* Collaborative, project-driven environment with strong pipeline
* Competitive daily rate, reflective of the technical expertise required
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0) .