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Quality Assurance Specialist

Quality Assurance Specialist

Leanbio S.L.Sant Quirze del Vallès, Cataluña, España
Hace más de 30 días
Descripción del trabajo

Leanbio is a leading Biopharmaceutical CDMO offering end-to-end services in recombinant proteins, mRNA, and pDNA. With over a decade of expertise, we have a proven track record in developing and manufacturing therapeutic molecules such as antibodies, Fab fragments, ADCs, enzymes, complex proteins, mRNA, and pDNA.

Leanbio has collaborated with over 100 candidates, some in late clinical stages. We are expanding our development and manufacturing capabilities with a new GMP site in Barcelona, spanning over 4,000 sqm, with three manufacturing areas : one for mammalian expression systems up to 2000L, another for microbial and yeast up to 1000L, and a third for mRNA up to 50L.

The new facility includes state-of-the-art development laboratories, outstanding Quality control rooms, and a warehouse. Leanbio is a global service provider for biologics development and manufacturing. Our commitment to excellence is demonstrated through :

  • Prioritizing customer satisfaction.
  • Providing cutting-edge end-to-end services.
  • Utilizing state-of-the-art facilities.
  • Offering extensive expertise in biologics.

We are seeking a QA Specialist to join our team at our new facilities in Sant Quirze del Vallès.

MAIN RESPONSIBILITIES :

  • To collaboratively build, with oversight from the Head of Quality Assurance, the Quality Management System, including creating and approving Standard Operating Procedures to support GMP manufacturing activities.
  • To develop and manage the Documentation Management System and related training programs.
  • To lead the supplier qualification program, including approving new suppliers and managing supplier status throughout their lifecycle.
  • To review Technical Agreements between the company and suppliers or clients.
  • To review batch documentation for release purposes.
  • To support qualification activities for facilities, utilities, and equipment, including approving protocols and final reports, and managing related change control records.
  • REQUIREMENTS :

  • Bachelor’s degree in a Science field with proven experience in GMP Quality Assurance roles.
  • Deep knowledge of managing Quality Management Systems, including deviations, CAPA, change controls, audits, and supplier qualification.
  • Experience in batch release activities, acting as a QP deputy, is a plus.
  • Experience in facilities, utilities, and equipment qualification.
  • Excellent problem-solving and decision-making skills.
  • Team player with excellent verbal and written communication skills in both Spanish and English, and strong analytical and organizational skills.
  • #J-18808-Ljbffr

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    Quality Assurance Specialist • Sant Quirze del Vallès, Cataluña, España

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