ABOUT LEANBIO
Leanbio is a CDMO that develops and manufactures biopharmaceutical products as New biological entities and Biosimilars, located in Barcelona.
* Leanbio follows a knowledge-based strategy, applying cutting edge technological platforms and working altogether with customers.
* Leanbio is currently building a new GMP manufacturing facility with state-of-the-art technology that will cover all phases of the production process.
ROL DESCRIPTION
Perform routine and non-routine physicochemical analyses of raw materials, intermediates, and finished products using techniques such as: HPLC (High-Performance Liquid Chromatography), Karl Fischer titration (moisture determination), FTIR / IR (identification of materials), Loss on Drying (LOD), Potentiometric titrations, Residue on Ignition (ROI), pH, conductivity, osmolality, TOC, etc.
Carry out sampling and analysis of water systems, including: Water for Injection (WFI).
Support environmental monitoring activities, including: surface and air sampling in classified areas.
Ensure strict adherence to GMP and ALCOA++ data integrity principles, maintaining complete, accurate, and traceable documentation.
Document all activities clearly and contemporaneously in lab notebooks, logbooks, or electronic systems (e.g., LIMS), in compliance with internal SOPs.
Participate in quality system activities, such as investigation of OOS / OOT results and reporting of deviations and support in CAPA implementation.
Maintain and calibrate laboratory equipment, performing routine checks and informing of any malfunction or need for maintenance.
Follow safety protocols and contribute to keeping the lab in a clean condition at all times.
Collaborate with cross-functional teams, including QA, production, and validation, when needed.
OFFERED
* Type of professional relationship: Contract
* Type of contract: Permanent
* Hours week: 40 hours
* Schedule: Intensive with flexible start times. Possibility of organizing shifts
* Gross annual salary: 30k-45k depending on experience
* Powerful professional development and growth contributing to the creation of the Quality Control department from scratch, and supporting GMP activities of the new manufacturing facility
* Be a part of a CDMO company that works with multiple biological products. You will have the opportunity to gain perspective of the life-cycle of a biological product.
Requisits : REQUERIMENTS
* Education: o. Master Oficial (Bolonia) - o. Master Oficial (Bolonia), m. Doctorat - m. Doctorat
* Advanced Training in Laboratory Analysis and Control with 2–5 years of experience in Quality Control in a GMP-regulated pharmaceutical environment.
* Practical experience in physicochemical testing including HPLC, Karl Fischer, IR, Loss on Drying, potentiometric titrations, and Residue on Ignition.
* Skilled in sampling and analysis of pharmaceutical water systems (WFI, Purified Water) following USP / EP methods.
* Familiarity with environmental monitoring in cleanroom environments is an asset.
* Strong knowledge of ALCOA++ principles and GMP documentation practices.
* Experience with quality systems (OOS, deviations, CAPAs, change control).
* Proactive team player with good organizational skills and the ability to work independently.
* Fluent in Spanish with basic to intermediate English communication skills (reading / writing preferred).
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