Quality Assurance Specialist II
Confirmed live in the last 24 hours
Orca Bio

51-200 employees

Clinical-stage cell therapy company
Company Overview
Abata's mission is to translate the biology of regulatory T cells (Tregs) into transformational medicines for patients with progressive multiple sclerosis and other serious autoimmune and inflammatory diseases. Abata is bringing an entirely new approach to the treatment of autoimmune disease by engineering Tregs as targeted therapies that stop immune-mediated destruction, restore homeostasis – a state of harmony – and promote repair in the affected tissues.
Biotechnology

Company Stage

Series D

Total Funding

$375M

Founded

2016

Headquarters

Menlo Park, California

Growth & Insights
Headcount

6 month growth

4%

1 year growth

19%

2 year growth

38%
Locations
Sacramento, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
QA & Testing
Quality Assurance
Requirements
  • Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 5+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 3+ years of experience
  • Moderate understanding of quality systems processes
  • Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred, including raw material release
  • Able to meet project and testing timelines
  • Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management
  • Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment
Responsibilities
  • Perform routine inspection and release of raw materials
  • Support batch record release activities
  • Support review of logbooks, procedures and protocols
  • Act as a system administrator for master control as back-up support
  • Perform review of quality records such as deviations, change controls and CAPAs
  • Track completion of quality records and maintain metrics
  • Receive and provide training
  • Perform other duties as requested by supervisor/manager to support Quality
  • Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products