Quality Assurance Specialist

Quality Assurance Specialist

Competitive Pay – Desirable Hours – Excellent Organization!

Astrix is seeking an experience QA Specialist to join our client in the Louisville, Kentucky area. This is an excellent opportunity to work as a multi-functional site leader for a well-renowned pharmaceutical company.


  • Serving as local business process owner (BPO) for several company quality system elements to ensure their compliance and timely execution and continuous improvement.
  • Ensuring site operations, equipment, processes and product comply with local, regional, and corporate procedures
  • Maintaining controlled material status and distribution authorizations to ensure timely supply availability for distribution operations
  • Collecting, analyzing and reporting site Quality System metrics for the site leadership team to ensure effective Quality System monitoring.
  • Confirming technical quality and compliance for Validation, Facilities, Change Control, Investigations, Operations to ensure technically- and scientifically-sound, and GMP-compliant technical decisions and documentation.


  • BS Degree in Chemistry, Microbiology, or Engineering, or Science/Pharmaceutical field.
  • 10 years’ experience in pharmaceutical GMP commercial operations
  • 5+ years direct experience in implementing or managing pharmaceutical / biologics GMP commercial quality management systems and processes
  • Solid and broad understanding of key pharmaceutical GMP Quality Systems

Preferred Qualifications:

  • 15+ years pharmaceutical / GMP commercial operations
  • Professional Certifications in Compliance, Quality Management, Quality Engineering, or Lean Six Sigma.
  • Knowledge of pharmaceutical distribution
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