Fenton, MO
95K

Responsibilities: 

• Hiring, and training employees; planning, assigning, directing work; appraising performance of employees.
• Sets and deliver on individual and team goals that support the department and site strategy. Takes personal accountability for both his/her own and the team’s actions.
• Contributes in preparation and monitoring of budgets through regular analysis of cost and spending.
• Capable of writing and reviewing deviations, out of specification /lab investigations, and corrective/preventative actions (CAPA) lab investigations utilizing tools like 6M, 5 Why’s etc.
• Responsible for regulatory audit responses.
• Implement and manage QC related SOPs and processes. Monitor data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records.
• Responsible for timely testing and releases of raw materials, in-process, finished products, stability samples from the lab.
• Responsible for reviewing changes in compendial methods for applicable products and notifies management of such changes in order to determine appropriate course of action.