Weekend QC Micro Analyst for CAR-T Europe

Johnson & Johnson; Belgique; Sur place; EUR 43 000 - 59 000; Plein temps

Résumé du poste

Johnson & Johnson Beerse, Belgium, is seeking a QC Micro Analyst, CAR-T Europe, to perform and review microbiological testing supporting CAR-T production in a cGMP QC lab. The role emphasizes data integrity, compliance, and patient safety, with weekend shifts Saturdays and Sundays 6:00 AM–6:00 PM.

You will maintain SOPs, assist with investigations and CAPAs, and collaborate across functions while ensuring testing aligns with USP/EP/JP standards and regulatory requirements.

Qualifications

• Bachelor's degree in a Scientific discipline or related field.
• Minimum of 2 years of experience in a cGMP-compliant Quality Control laboratory or similar regulated environment.
• Strong understanding of microbiological testing principles and interpretation of microbiological data.
• Experience with microbiological laboratory techniques, including aseptic practices, endotoxin testing, growth promotion testing, sterility testing, and environmental monitoring.
• Knowledge of compendial requirements (USP, EP, JP) is preferred, along with proficiency in Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
• Excellent written and verbal communication skills; prior CAR-T, cell therapy, or biopharmaceutical experience is highly desirable.

Responsabilités

• Perform microbiological testing and analytical activities in compliance with GMP regulations, approved procedures, and quality specifications.
• Review laboratory data to ensure accuracy, completeness, compliance, and data integrity.
• Author, revise, and maintain SOPs, Work Instructions (WIs), and laboratory protocols within the document management system.
• Support laboratory investigations, deviations, CAPAs, and other quality-related activities.
• Assist with internal audits and maintain inspection readiness within the QC Microbiology laboratory.
• Participate in laboratory and cross-functional meetings, providing technical input and representing the QC team when required.

Connaissances

Microbiological testing principles

Aseptic practices

Endotoxin testing

Growth promotion testing

Sterility testing

Environmental monitoring

Data interpretation

Formation

Bachelor's degree in a Scientific discipline

Outils

MS Office

Description du poste

Johnson & Johnson Beerse, Belgium, is seeking a QC Micro Analyst, CAR-T Europe, to perform and review microbiological testing supporting CAR-T production in a cGMP QC lab. The role emphasizes data integrity, compliance, and patient safety, with weekend shifts Saturdays and Sundays 6:00 AM–6:00 PM.

You will maintain SOPs, assist with investigations and CAPAs, and collaborate across functions while ensuring testing aligns with USP/EP/JP standards and regulatory requirements.