Senior Qc Specialist _ Micro

Takeda

Tianjin, China
Microbial limit and sterility testing
Environmental monitoring
Laboratory equipment maintenance
Responsible for the management of reagents, test solutions, consumables, culture media, and cell cultures for biological product testing, including establishing new management systems and processes

Job Summary

  • Responsible for the management of reagents, test solutions, consumables, culture media, and cell cultures for biological product testing, including establishing new management systems and processes.
  • Conducts laboratory microbial limit and sterility testing, environmental monitoring of water systems, compressed air, and clean areas, and ensures proper functioning of laboratory equipment.
  • Maintains documentation such as SOPs, quality standards, and inspection records, and participates in continuous improvement projects for microbiological analysis methods and processes.

Matching Summary

Responsible for the management of reagents, test solutions, consumables, culture media, and cell cultures for biological product testing, including establishing new management systems and processes.

Skills & Requirements

Must-have

  • Microbial limit and sterility testing
  • Environmental monitoring
  • Laboratory equipment maintenance
  • SOP maintenance and optimization
  • EHS compliance

Nice-to-have

  • Collaboration with suppliers and headquarters
  • Continuous improvement projects
  • New analytical instrument verification

Key Requirements

  • Gap analysis of regulations and SOPs
  • Analytical method validation
  • Microbial equipment validation and qualification
  • AIQ verification of new analytical instruments
  • Computerized system review and upgrade

Work Rights

Not specified

Tailored Resume

Cover Letter