Specialist, Quality Assurance - Day Shift

Orca Bio

Sacramento, CA, United States
**
Managing quality systems
Deviation system management
Batch disposition decisions
** Orca Bio is seeking a Specialist for Quality Assurance to join their Sacramento, CA facility, focusing on managing quality systems in the production of next-generation cell therapies aimed at treating blood cancer. The role requires overseeing various quality processes and making critical decisions to ensure product integrity before release. **

Job Summary

  • Orca Bio is a late-stage biotechnology company developing next-generation cell therapies to improve survival rates and reduce risks for blood cancer patients.
  • The Specialist, Quality Assurance role manages critical quality systems including deviations, change control, CAPA, and document management within a dedicated clinical manufacturing facility.
  • This position involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing required for patient trials.

Matching Summary

Match Score: 75

** Orca Bio is seeking a Specialist for Quality Assurance to join their Sacramento, CA facility, focusing on managing quality systems in the production of next-generation cell therapies aimed at treating blood cancer. The role requires overseeing various quality processes and making critical decisions to ensure product integrity before release. **

Skills & Requirements

Must-have

  • managing quality systems
  • deviation system management
  • batch disposition decisions
  • corrective and preventive actions
  • change control processes
  • document management

Nice-to-have

  • rapid processing times support
  • patient impact focus
  • clinical trial experience

Key Requirements

  • experience with quality systems
  • knowledge of deviation management
  • CAPA and change control expertise
  • batch disposition decision-making skills

Work Rights

Not specified

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