Quality Control Analyst – Bioassay
Leanbio is a leading Biopharmaceutical CDMO offering end-to-end services in recombinant proteins, mRNA and pDNA. With over a decade of expertise, Leanbio has developed and manufactured therapeutic molecules including antibodies, Fab fragments, ADCs, enzymes, complex proteins, mRNA and pDNA. The new GMP site in Barcelona (Sant Quirze del Vallès) features >4,000 m2 with three manufacturing areas: mammalian expression systems up to 2000 L, microbial/yeast up to 1000 L, and mRNA up to 50 L, plus state-of-the-art development laboratories and Quality control rooms.
MAIN RESPONSIBILITIES:
* Perform cell proliferation methods and other bioassays to verify the potency of biotechnology products, according to USP, EP, and internal methodologies.
* Cell bank production, characterization 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 a clean, organized, and compliant laboratory environment.
* Collaborate effectively with QA, production, validation, and other cross-functional teams to support quality assurance and compliance.
REQUIREMENTS:
* 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 assays, following USP and EP methods.
* Skilled in cell culture. Strong knowledge of ALCOA++ data integrity principles and GMP documentation practices.
* Experience 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 regulatory compliance.
* Fluent in Spanish with basic to intermediate English (reading and writing preferred).
Position Details:
* Seniority level: Associate
* Employment type: Full-time
* Job function: Analyst
* Industries: Biotechnology, Research and Pharmaceutical Manufacturing
We are looking for a new person to join the QC team at our Sant Quirze del Vallès facility.
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