Senior Specialist, Qc Cell

Astrazeneca

Qc cell group daily inspection
Laboratory area normal daily management
Analytical method validation implementation
Participate in the daily inspection and management of the QC cell group, including work arrangements and tracking, and establishing the document system, to complete the inspection tasks of the group in a timely and efficient manner, and ensure that inspection activities comply with domestic and foreign laws and regulations and internal company quality requirements

Job Summary

  • Participate in the daily inspection and management of the QC cell group, including work arrangements and tracking, and establishing the document system, to complete the inspection tasks of the group in a timely and efficient manner, and ensure that inspection activities comply with domestic and foreign laws and regulations and internal company quality requirements.
  • Participate in the normal daily management of the QC cell group laboratory area and ensure its normal operation, and assist in the continuous improvement of the QC laboratory quality system.
  • Organize the implementation of analytical method validation for the QC cell group and the writing of validation reports, ensuring the effectiveness of analytical methods.

Matching Summary

Participate in the daily inspection and management of the QC cell group, including work arrangements and tracking, and establishing the document system, to complete the inspection tasks of the group in a timely and efficient manner, and ensure that inspection activities comply with domestic and foreign laws and regulations and internal company quality requirements.

Skills & Requirements

Must-have

  • QC cell group daily inspection
  • laboratory area normal daily management
  • analytical method validation implementation
  • complex instrument SOP drafting
  • release testing of samples
  • stability study plan formulation
  • preparation reagent management

Nice-to-have

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

Key Requirements

  • Bachelor's degree or above
  • 3+ years of QC experience in biopharmaceutical industry
  • 2+ years of GMP environment work experience
  • Cell therapy related experience preferred
  • CET-6 or above English proficiency
  • Cell culture theoretical knowledge
  • Flow cytometry theoretical knowledge
  • CAR-T cell culture experience preferred
  • Analytical method validation experience preferred
  • OOS, deviation handling experience preferred

Work Rights

Not specified

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