Victoria Smith

· Develop and execute laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics

· Authors technical documents, such as protocols, batch records, test methods, technical reports, and operating procedures

· Review technical documents for accuracy, thoroughness, and regulatory compliance

· Trains, coaches or mentors’ others on technical development or business issues

· Direct work of technical staff, including work assignments

· Management of intern staff and projects

· Supervised customer interaction on team meetings

· Knowledge of high-shear granulation, dry granulation/roller compaction, wet granulation, fluid-bed technology, compression, encapsulation, and coating

· Executes efficiency improvement project with moderate guidance

· Identify and recommend business opportunities on a project specific basis

· Has advanced knowledge of the principles, theories, and concepts applicable to a limited range of work in pharmaceutics and knowledge of principles and concepts in other disciplines.

· Applies technical and functional knowledge to assist in experiment/project design that will enable department to meet goals.

· Executes testing procedures for the identification and characterization of raw materials, stability, and finished products. Techniques include, not limited to: HPLC, GC, Karl Fischer, particle size, trace metals, FTIR and dissolution.

· Analyzes data, documents results, and maintains laboratory documentation according to cGMP, GDP, and internal guidelines.

· Communicates results in written and oral presentations and logs results into database as required.

· Writes procedures, specifications, and test methods

· Performs review of laboratory documentation.

· Participates in assigned improvement projects.

· Execute testing procedures on raw material, in-process, finished product, and stability samples such as but not limited to HPLC, GC, ICP, dissolution, particle size

· Compendia testing as per USP, EP, and JP

· Maintain laboratory documentation according to cGMP and GDP

· Order and keep inventory of standards used for testing of pharmaceuticals

· Send out purified water every week to check for microbial quality and review results

· Train new employees as needed

· Writes procedures, specifications, and test methods

· Performs review of laboratory documentation

· Perform testing on oral, urine, and blood samples as per SOPs and STMs

· Reagent preparation and restock

· Train new employees

· Perform group lead duties when lead was absent