Quality Control Engineer

3 weeks ago

Hyderabad, Telangana, India TekOne IT Services Pvt. Ltd. Full time

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:

  • Strong attention to detail, organizational, and analytical skills.
  • Excellent written and verbal communication skills.
  • Ability to work collaboratively in a fast-paced team environment.
  • Certifications: GMP/GLP certification or equivalent is a plus.

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