1) Coordinates out-of-specification investigations, implements corrective actions, suggests, and implements continuous improvements.
• Prepares records necessary to track “hold” items. Conduct Out of Specification investigations on raw materials, bulk, finished goods, and contract manufactured products.
• Ensures all quantities of affected materials or items are accounted for and appropriately held to prevent use or distribution.
• Provides technical expertise and supports cross-functional investigations
2) Communicates testing results in a timely manner to internal and external customers including technical interpretations and recommendations. Interacts frequently with customer groups concerning cross-functional projects and lab throughput
3) Ensures timely communication to customers and Quality management regarding Operation issues, out-of-specifications, deviations, and coordinate external testing.
4) Responsible for the IQ/OQ/PQ, calibration, and maintenance of laboratory equipment including coordinating calibrations from external vendors.
5) Possess an understanding of current FDA regulations and Good Manufacturing Practices to ensure compliance.
6) Perform laboratory testing (as needed)