Test to a high, and continuously improving, level of GMP/GLP compliance to ensure patient safety and to minimize risk to the company business
Perform routine testing and basic GMP paperwork review with supervisor direction
Oversee the development and tracking to a plan for day-to-day testing activities to meet the daily manufacturing and batch disposition schedule while maintaining the highest levels of GMP compliance
Full responsibility for the operation of the laboratory
Frequently review staff training to ensure that that it meets the requirements of the laboratory and fulfil the needs and aspirations of the individual
Enhancements and improvements to current commercial processes
DCMC Team participation for establishment of sample points and limits/specifications for current products/interfacing with various R&D; groups
Periodic review of microbial limits
Excursion and contamination response harmonization
Analyzes data and results and provides conclusions and proposals for future directions