This offer is part of the Job Marketplace of the Health Sector Talent event, which will take place in person at the Employment Fair on October 15th from 3:30 PM to 6:30 PM, organized by Barcelona Activa in collaboration with the Health Hub Barcelona.
LEANBIOxxxx company needs to fill sales assistant vacances : Physicochemical Quality Control Analyst
Only those who meet the company's requirements will be notified.
Attendance and details will be confirmed by email.
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.
REQUIREMENTS
* Education: Master Oficial (Bolonia) or 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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