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Quality Assurance Specialist III - Remote

Posted 34 weeks ago
QA
Full Time
United States
$91,217 - $111,487/year

Overview

The QA Specialist III will provide QA support for Quality Operations in a fast-paced pharmaceutical environment, focusing on QA activities and requiring diverse skill sets.

In Short

  • Support reporting of Quality metrics
  • Support quality risk management frameworks
  • Perform batch record review
  • Evaluate compliance of manufacturing records
  • Maintain Continued Process Verification data
  • Review Quality System documentation
  • Evaluate document changes for compliance
  • Support analysis of quality trends
  • Conduct QA oversight activities
  • Support training for employees

Requirements

  • Bachelor’s degree in science or equivalent experience
  • 7+ years of GxP experience
  • Experience in a manufacturing setting
  • Knowledge of quality risk assessment
  • Extensive knowledge of GMP regulations
  • Experience with Quality Assurance systems
  • Strong technical writing skills
  • Advanced software skills
  • Effective communication skills
  • Strong team player

Benefits

  • 401(k) plan with employer match
  • 12 weeks of paid parental leave
  • Health plans (medical, dental, vision)
  • Life insurance and disability
  • Flexible time off
  • Annual Winter Holiday shut down
  • At least 11 paid holidays

Ardelyx

Ardelyx

Ardelyx is a publicly traded biopharmaceutical company dedicated to discovering, developing, and commercializing innovative first-in-class medicines that address significant unmet medical needs. With two approved commercial products in the United States, IBSRELA® and XPHOZAH®, Ardelyx is actively expanding its reach through partnerships for the development and commercialization of its products in international markets, including Japan and Canada. The company is committed to improving patient outcomes and is focused on creating impactful healthcare solutions.

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