QC Planner

• Coordinates sample management for QC laboratories. 
• Collaborate with cross-functional teams to develop and implement QC sampling and testing strategies. 
• Develop and maintain reference standard, reagent and consumable inventory levels to prevent stockouts or overstock situation for the QC laboratories. Implement inventory control measures and optimize stock rotation.  
• Interprets and communicates special requirements to appropriate personnel. 
• Updates new plans and changes in the inventory management system. 
• Develop and maintain sampling plans for incoming, production and stability samples.  
• Ensures schedule stability by minimizing short term changes. 
• Maintains equipment calibration and maintenance schedules.  
• Responsible for updating existing reports and developing new ones. 
• Responsible for tracking departmental performance metrics, as required. 
• Work closely with all internal and external suppliers and vendors. 
• Maintain work area to 6S standards as posted in work area. 
• Maintain SOPs (Standard Operating Procedure) for all duties and tasks. 

Required experience or skills: 

• Minimum of 3 years of biopharma industry experience, of which at least 2 years have been in a role of hands-on experience with Quality Control in a regulated environment.
• Associate or bachelor’s degree, preferred. 
• Project management and awareness of scheduling tools.   
• First-hand experience participating in and/or hosting audits/inspections related to Quality Control.
• Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, SharePoint, PowerBI etc.).