Quality Control Analysts
Sysintel Inc · Greenville, SC · 3 mo ago
Quality AssuranceFull-time
Responsibilities
- Analyze validation test data to determine whether systems or processes have met validation criteria.
- Conduct validation of equipment and processes in compliance with FDA standards.
- Implement and maintain the effectiveness of the Quality System as per ISO 13485.
- Support the Risk Management process per ISO 14971 and construction/maintenance of the Risk Management File.
- Assist in the change control process; participate in method validations and development to support R&D product development.
- Complete GMP documentation needed to support release of raw materials, intermediates, and final products.
Requirements
- Master’s degree in Science, Health Science, Pharmaceutical Science, Technology, or Engineering (any).
Skills
- Corrective Action and Preventive Action (CAPA)
- Good Manufacturing Practice (GMP)
- Failure Mode Effective Analysis (FMEA)
- Root Cause Analysis
- GAP Analysis
- Design Control
Work location: Greenville, SC and various unanticipated locations throughout the U.S.