Quality Control Engineer

Quality Control (QC) Specialist – CAR-T Cell Therapy - H1B Sponsorship

Job Summary :

We are seeking a highly motivated and detail-oriented Quality Control (QC) Specialist to join

our CAR-T Cell Therapy team. This individual will be responsible for ensuring the quality,

safety, and compliance of CAR-T products through testing, documentation, and quality

assurance practices. As a key member of the QC team, you will play a critical role in the

release of CAR-T cell therapies for clinical and commercial use.

Key Responsibilities :

• Perform Analytical Testing : Conduct quality control testing of CAR-T cell products, including but not limited to assays such as cell viability, potency, sterility, endotoxin, mycoplasma, and genetic testing.
• Sample Management : Oversee the collection, processing, and storage of in-process and final product samples.
• Ensure appropriate documentation and tracking of samples for testing.
• Data Review & Documentation : Review analytical results and ensure compliance with all regulatory requirements and internal SOPs. Prepare and approve analytical data reports and lab notebooks.
• Equipment Qualification and Calibration : Support the qualification, calibration, and routine maintenance of QC equipment to ensure it is properly functioning and compliant with Good Manufacturing Practices (GMP).
• Batch Release : Participate in the review and release of CAR-T product batches, ensuring all quality standards and specifications are met before product release.
• Investigation & CAPA : Assist in investigating deviations, non-conformances, and customer complaints. Help implement corrective and preventive actions (CAPA) as needed.
• Collaboration with Cross-functional Teams : Work closely with other departments, including Manufacturing, Regulatory, and Research and Development, to ensure product quality meets expectations and requirements.
• Compliance & Regulatory : Ensure compliance with GMP, GLP, and FDA / EMA regulations. Stay up-to-date on CAR-T regulatory requirements and industry standards.
• Training : Provide training and mentorship to junior QC staff as required, ensuring they understand QC processes, standards, and regulatory requirements.

Skills :