Senior Quality Control Specialist

20 hours ago


Fremont, California, United States Ardelyx Full time
Job Description

The Quality Assurance Specialist III will provide QA support for Quality Operations, working in a fast-paced pharmaceutical environment with a broad scope of responsibilities. Key responsibilities include:

  • Supporting the reporting of Quality metrics on a monthly and quarterly basis
  • Supporting various quality risk management frameworks
  • Performing batch record review and product dispositions
  • Evaluating compliance of completed manufacturing records
  • Maintaining Continued Process Verification data collection

This role requires strong document and quality risk assessment management experience in a GxP environment. The successful candidate will have a Bachelor's degree in science or equivalent relevant experience, with 7+ years of combined GxP experience in drug substance and drug product manufacturing process development, commercial manufacturing, analytical development, and/or quality control experience in biotechnology or pharmaceutical industries.



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