QC Associate

19 hours ago

Hyderabad, Telangana, India Randstad Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

  • Perform in-process and release testing of CAR-T products.

  • Conduct assays including flow cytometry, qPCR, ELISA, and microbiological

assays.

  • Develop, validate, and transfer analytical methods for CAR-T product testing.

  • Troubleshoot analytical methods and provide technical support during investigations.

  • Analyze and interpret QC data, prepare statistical reports, and present results to teams.

  • Author, review, and approve QC protocols, procedures, and documentation.

  • Ensure regulatory compliance with GMP QC protocols across PoC centers.

  • Manage lab supplies, reagents, and inventories effectively.

  • Lead investigations of OOS/OOT results, generate deviation reports, and execute CAPA.

Preferred candidate profile

  • Bachelors/Masters degree in Biotechnology, Life Sciences, or related field.

  • Minimum 5 years of QC experience in biologics or cell therapy manufacturing.

  • Hands-on experience with PCR is highly desirable.

  • Strong understanding of GMP and QC documentation practices.

  • Willingness to travel extensively across India for the first two years.

  • Excellent analytical, organizational, and communication skills.

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