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.
LeanBioPro company needs to fill sales assistant vacances: Bioassay Quality Control Analyst
Only those who meet the company's requirements will be notified.
Attendance and details will be confirmed by email.
ABAUT BIOPRO
* 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.
ROLE DESCRIPTION
Perform cell proliferation methods and others bioassays to verify the potency of biotechnology products, according to to USP, EP, and internal methodologies. Cell bank production, caracterization and release management. Maintain detailed and contemporaneous records in laboratory notebooks, logbooks, or electronic systems (LIMS).
Participate in quality system activities including investigation of OOS/OOT microbiological results, deviation reporting, and support in CAPA implementation. Maintain laboratory equipment calibration and functionality and promptly report any malfunctions or maintenance needs. Follow all biosafety and safety protocols contributing to maintaining a clean, organized, and compliant laboratory environment. Collaborate effectively with QA, production, validation, and other cross-functional teams to support quality assurance and compliance.
* Tipus de relació professional: Contracte
* Tipologia de contracte: Indefinit
* Núm. Hores setmanals: 40h
* Horari: Intensiu amb flexibilitat d'entrada. Posibilitat d'organitzar-se en torns
* Retribució brut anual: 30k-45k segons experiencia.
Requisits:
REQUIRED
* Advanced training in bioassays analysis with 2 to 5 years of proven experience in Quality Control within a GMP-regulated pharmaceutical environment.
* Practical expertise in bioassays used in biotechnology, including cell proliferation assay, following USP and EP methods. Skilled in cell culture.
* Strong knowledge of ALCOA++ data integrity principles and GMP documentation practices.
* Experienced in managing quality systems including Out of Specification (OOS) investigations, deviation reporting, CAPA implementation, and change control.
* Proactive team player with strong organizational skills and the ability to work independently while ensuring strict compliance with regulatory requirements. Fluent in Spanish with basic to intermediate English communication skills (reading and writing preferred).
* Categoria professional: Tècnics superiors i assimilats
* Education: reglada requerida: m. Doctorat - m. Doctorat, o. Master Oficial (Bolonia) - o. Master Oficial (Bolonia)