Anna Cale Email & Phone Number

• Ensure adherance to cGMPs, federal and international regulations, and internal processes and procedures for assuring quality
• Quality and compliance oversight of the Supply Chain, Warehouse, Distribution, and Quality Control Laboratories
• Approve/reject analytical results for all raw materials, in-process materials, and drug products in accordance with specifications
• Review and approve documents to ensure that they are in compliance with cGMPs, federal and international regulations, and consistent with internal policies and procedures
• Participate in internal and external audits
• Project management

• Data approval and audit of work to ensure it is completed in compliance with cGMPs, federal regulations, safety regulations, and internal policies and procedures
• Lead Analyst and Trainer
• Analysis Techniques: Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis, Isoelectric Focusing, High Performance Liquid Chromatography and Capillary Electrophoresis
• Analytical research, method development, validation and transfer
• Technical writing including method validations, procedure development, and analytical methods
• Manage up to eight direct reports

· Provide customer support for various types of food operations management and nutritional software· Quality assurance testing for new software releases · Write documentation for software · Update nutritional software