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Quality Assurance Specialist in Biotechnology

Quality Assurance Specialist in Biotechnology

beBeeBioassaySant Quirze del Vallès, Cataluña, España
Hace 17 días
Descripción del trabajo

Overview

Leanbio offers a dynamic role as Bioassay Quality Control Analyst within our Biopharmaceutical Contract Development and Manufacturing Organization (CDMO). We provide end-to-end services in the field of recombinant proteins, mRNA and plasmid DNA.

We have a proven track record in development and manufacturing of therapeutic molecules such as antibodies, Fab fragments, antibody-drug conjugates, enzymes, complex proteins, mRNA and plasmid DNA.

The new facility includes state-of-the-art development laboratories, outstanding quality control rooms and warehouse. Our global service provider for biologics is looking for a skilled professional to join the QC team :

Responsibilities

  • Perform cell proliferation methods and other bioassays to verify the potency of biotechnology products.
  • Maintain accurate records in laboratory notebooks or electronic systems.
  • Participate in quality system activities including investigation of out-of-specification results.
  • Maintain laboratory equipment calibration and functionality.
  • Follow all biosafety and safety protocols contributing to maintaining a clean and compliant laboratory environment.

Qualifications

  • The ideal candidate will have advanced training in bioassays analysis with 2 to 5 years of experience in Quality Control within a GMP-regulated pharmaceutical environment.
  • Practical expertise in bioassays used in biotechnology, including cell proliferation assay.
  • Skilled in cell culture and knowledgeable about ALCOA++ data integrity principles and GMP documentation practices.
  • Experienced in managing quality systems including out-of-specification investigations and change control.
  • Proactive team player with strong organizational skills and ability to work independently.
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    Quality Assurance Specialist • Sant Quirze del Vallès, Cataluña, España

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