Senior Specialist, Qc Cell

AstraZeneca

Suzhou, China
Qc cell group daily inspection
Document system establishment
Cell culture operations
Participate in the daily inspection and management of the QC cell group, including work arrangements and tracking, and establishment of the document system, to complete inspection tasks efficiently and ensure compliance with regulations

Job Summary

  • Participate in the daily inspection and management of the QC cell group, including work arrangements and tracking, and establishment of the document system, to complete inspection tasks efficiently and ensure compliance with regulations.
  • Organize the implementation of analytical method validation and write validation reports to ensure the effectiveness of analytical methods.
  • Organize personnel to conduct release testing and quality research testing of materials, lentiviral vectors, and CAR-T samples according to the plan, ensuring the authenticity and reliability of inspection data.

Matching Summary

Participate in the daily inspection and management of the QC cell group, including work arrangements and tracking, and establishment of the document system, to complete inspection tasks efficiently and ensure compliance with regulations.

Skills & Requirements

Must-have

  • QC cell group daily inspection
  • document system establishment
  • cell culture operations
  • flow cytometry analysis
  • method validation experience
  • handle OOS and deviations

Nice-to-have

  • fast-paced environment
  • low error tolerance
  • adapt to shift work
  • strong pressure resistance

Key Requirements

  • Bachelor's degree or above
  • 3+ years QC experience in biopharmaceutical
  • 2+ years GMP environment experience
  • English CET-6 or above

Work Rights

Not specified

Tailored Resume

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