Ensure the manufacture of allergenic extract prescriptions comply with USDA regulations. Prepare regulatory submissions to the USDA, CCVB and other international agencies. Ensure cleanroom and laboratory equipment is maintained and certified. Review and approve documentation of prescription labeling and manufacturing records. Purchase laboratory raw material, supplies and equipment. Implemented new manufacturing procedures and revised SOP's for new products. Provided the business requirements for the prescription laboratory software/web development.
Responsible for all aspects of the manufacture of allergenic extracts in an FDA regulated facility. Responsible for the preparation and allocation of raw materials, reagents and supplies for the manufacture of prescription and diagnostic test materials. Assisted in the development of software to accomplish a more efficient means of product recall and inventory control.
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