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