Quality Assurance Specialist

7 days ago

Noida, Uttar Pradesh, India beBeeBiochemist Full time ₹ 1,52,50,000 - ₹ 2,02,50,000

Are you a seasoned professional in quality control seeking to leverage your expertise in bioanalytical methods and microbiological testing?

Senior QC Scientist Role

We are looking for an experienced Senior Quality Control Scientist with 10+ years of hands-on experience in analytical and microbiological testing to support CAR-T manufacturing operations.

The ideal candidate will ensure product safety, potency, and compliance with cGMP and regulatory requirements through execution, oversight, and review of laboratory testing.

Key Responsibilities:
  • Perform and oversee advanced bioanalytical testing, including qPCR, flow cytometry, ELISA, cell count, and cell viability assays.
  • Manage and execute microbiological and environmental monitoring (EM) testing, including sterility, endotoxin, mycoplasma, and gram staining.
  • Review, analyze, and approve QC data to ensure accuracy, compliance, and timely release of results.
  • Support and guide junior chemists and scientists in laboratory best practices, method execution, and compliance requirements.
  • Lead and contribute to OOS/OOE investigations, deviations, and CAPA development, ensuring thorough root cause analysis and effective corrective actions.
  • Collaborate with cross-functional teams (Manufacturing, QA, Regulatory) to support clinical and commercial CAR-T manufacturing.
Required Skills and Qualifications:
  • Bachelor's or Master's degree in Chemistry, Biochemistry, Microbiology, or related field.
  • Minimum 10 years of progressive experience in Quality Control within pharmaceutical, biotechnology, or cell therapy environments.
  • Proven expertise in bioanalytical methods (qPCR, flow cytometry, ELISA) and micro/EM testing.
  • Strong understanding of cGMP, regulatory expectations (FDA/EMA), and quality systems.
  • Demonstrated ability to lead investigations, train staff, and provide technical oversight.
  • Excellent documentation, organizational, and communication skills.

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