Quality Control Engineer Job in TekOne IT
- Kpr sugar apperals
- 2 to 6 Yrs
- Hyderabad
- 10 months ago
- Email to a friend
- Report this job
Job Description
- 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.,
Employement Category:
Employement Type: Full timeIndustry: Medical / HealthcareRole Category: Not SpecifiedFunctional Area: Not SpecifiedRole/Responsibilies: Quality Control Engineer Job in TekOne ITContact Details:
Company: TekOne IT ServicesLocation(s): Hyderabad+ View Contact
Keyskills: Analytical Testing Sample Management Batch Release Training Equipment Qualification Calibration
Fraud Alert to job seekers!
₹ Not Specified
Similar positions
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in