Quality Control Technician

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

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

The new facility includes state-of-the-art development laboratories, oustanding Quality control rooms and warehouse. Leanbio is a global service provider for the development and manufacturing of biologics. Our commitment to excellence is evident in everything we do:

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

We are looking for a new person to join the team as a Quality Control Technician in our brand new facilities in Sant Quirze del Vallès:

MAIN RESPONSIBILITIES:

• Execution and supervision of protein analysis for evaluating the quality attributes of biotech products. Ensure strict compliance with GMP standards and ALCOA+ data integrity principles, keeping complete, accurate, and traceable documentation.
• Document all activities clearly and accurately in lab notebooks, analysis records, or electronic systems (e.g., LIMS), following internal procedures.
• Manage processes in the QC Lab.
• Maintain the inventory and control of reagents and consumables, ensuring their availability and proper storage conditions.
• Participate in quality system activities, such as investigating OOS/OOT results, reporting deviations, and implementing CAPA.
• Manage the calibration and qualification of laboratory equipment, performing routine checks and reporting any malfunctions or maintenance needs.
• Ensure compliance with safety protocols and always keep the lab clean. Work with cross-functional teams, including Quality Assurance, Production, and MSAT, when needed.

REQUIREMENTS:

• Advanced training in protein analysis with over 3 years of proven experience in Quality Control within a GMP-regulated pharmaceutical environment.
• Hands-on experience in physicochemical, biochemical, bioassays, and microbiological methods, including chromatography, electrophoresis, ELISA, PCR, spectrophotometric methods, cell culture techniques, and microbiological methods such as endotoxin determination and microbial enumeration.
• Technical proficiency in analytical methods and the ability to supervise assays.
• Strong knowledge of ALCOA+ principles and GMP documentation practices.
• Experience with quality systems (OOS, deviations, CAPAs, change control). Familiarity with the regulatory environment of the pharmaceutical industry.
• Knowledge of analytical method development, validations, analytical transfers, and QC Laboratory management systems.
• Good leadership skills and organizational ability.
• Quick adaptation to changes and rearranging priorities based on the company's needs.