QC Analyst

3 - 4 years

5 - 6 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Quality Control
  • Roles and Responsibilities
    • Conduct routine and non-routine analyses of in-process materials, finished products, raw materials, environmental samples, and stability samples.

    • Interpret test results, compare findings against specifications and control limits, and provide recommendations for batch release decisions.

    • Compile laboratory test data and perform appropriate scientific and statistical analyses.

    • Prepare and complete all documentation required to support testing procedures in compliance with regulatory standards.

    • Calibrate, validate, and maintain laboratory instruments and equipment.

    • Provide quality control data required for regulatory submissions.

    • Inspect, test, and approve raw materials used in the manufacturing process.

    • Ensure laboratory cleanliness, safety, and adherence to good laboratory practices at all times.

    • Support cGMP stability and in-process quality control (IPQC) testing for Cell and Gene Therapy (CGT) products.

    Qualifications Educational Requirements
    • Master s degree in Biotechnology, Life Sciences, or a related discipline.

    • cell-based assays

    • cGMP practices and documentation

    • Ability to independently perform assays involving:

      • Cell culture

      • Transfection and transduction

      • Physical titer and functional titer assays

      • Co-culture assays

      • Flow cytometry

    • Ability to write technical reports, protocols, and SOPs with regulatory understanding.

    Desired Qualities
    • Strong organizational skills

    • Problem-solving mindset

    • Ability to multitask effectively

    • Strong reporting and documentation skills

    • Excellent coordination abilities

    • Flexibility and adaptability

    • A collaborative team player

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