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.
Responsibilities:
- 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.
Qualifications:
- 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