Quality Assurance Specialist

19 hours ago


Wilmington, Delaware, United States AstrixTechnology LLC Full time
Job Overview

Astrix Technology LLC is seeking a highly skilled Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities
  • Evaluate raw material records and testing records to ensure compliance with regulatory requirements.
  • Disposition of raw materials and bulk batches per associated specifications.
  • Approve and/or author intermediate level written procedures and other documents.
  • Interact with plant personnel to ensure CGMP compliance.
  • Provide backup for other QA and plant site personnel as needed.
  • Monitor compliance with GMP requirements.
  • Collaborate with a team environment to achieve quality goals.
Requirements
  • Bachelor's degree in a scientific discipline or equivalent.
  • 2+ years of relevant experience in a Quality Assurance role in the pharmaceutical industry, or equivalent.
  • Working knowledge of US Drug Product GMP requirements and associated guidelines.
About Astrix Technology LLC

Astrix Technology LLC has been delivering information technology consulting, regulatory advisory services, and staffing solutions to the scientific community since 1995. We provide scientists to a broad spectrum of scientific-based industries, including pharmaceutical, biotech, and medical device.



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