QC Micro analist weekend

Job Description

The QC Micro Analyst, CAR-T Europe is responsible for preparing, performing, and reviewing microbiological testing activities that support the production of CAR-T therapies. Working within a cGMP-compliant Quality Control laboratory, the analyst ensures that all testing is conducted in accordance with approved procedures, regulatory requirements, and quality standards. The role supports laboratory operations through microbiological analysis, documentation management, investigations, audits, and cross-functional collaboration, while maintaining a strong focus on data integrity, compliance, and patient safety. This position is part of the weekend team, working Saturday and Sunday from 6:00 AM to 6:00 PM.

Key Responsibilities

• 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.

Requirements

• Bachelor's degree in a Scientific discipline or a related field.
• Minimum of 2 years of experience in a cGMP-compliant Quality Control laboratory or a 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.