Demo

Quality Assurance Specialist

Katalyst Healthcares and Life Sciences
Rochester, MN Full Time
POSTED ON 1/24/2025
AVAILABLE BEFORE 4/23/2025

Responsibilities :

  • Join a pioneering biotech company dedicated to advancing viro-immunotherapies and improving patient quality of life globally.
  • As a Quality Assurance Specialist at our client's innovative facility, you'll play a crucial role in upholding the integrity of groundbreaking therapies that have far-reaching impacts.
  • Impact patient lives by ensuring the highest quality in therapeutic development.
  • Contribute to groundbreaking work in viral, genetic, and cell-based therapies.
  • Competitive salary commensurate with experience and qualifications.
  • Robust benefits package including health, dental, life insurance, and a Simple IRA with employer match.
  • Professional growth in a dynamic and supportive environment.

Requirements :

  • Implement QA strategies and support GxP inspection readiness.
  • Perform audits ensuring compliance with regulatory standards.
  • Monitor and enhance laboratory quality assurance practices.
  • Develop compliance-related metrics and provide QA support across departments.
  • Manage training records and support both internal and external audits.
  • Hold a Bachelor's degree in a science-related field.
  • Expertise in GxP, GLP, GCP, and ISO standards.
  • Experience in a regulatory QA environment for at least 5 years.
  • Skills in data review and process audits are crucial.
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