Quality Assurance Specialist in Biotechnology

beBeeBioassay; Sant Quirze del Vallès; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A biopharmaceutical company in Sant Quirze del Vallès is looking for a Bioassay Quality Control Analyst. You will perform bioassays to verify the potency of biotechnology products and maintain quality system integrity. Candidates need 2 to 5 years of relevant experience in a GMP-regulated setting. Strong skills in bioassays, cell culture, and quality control are essential for this dynamic role.

Formación

• 2 to 5 years of experience in Quality Control within a GMP-regulated environment.
• Practical expertise in bioassays used in biotechnology.
• Knowledgeable about ALCOA++ data integrity principles.

Responsabilidades

• Perform cell proliferation methods and other bioassays.
• Maintain accurate records in lab notebooks or electronic systems.
• Participate in quality system activities and investigation.

Conocimientos

Bioassays analysis

Cell proliferation assay

Cell culture

Quality Control

Organizational skills

Descripción del empleo

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.