-Ensures compliance to applicable FDA and ISO requirements-Conducts GLP critical phase audits in labs for Genotoxicology, In-vitro, In-vivo and Histology, In-life studies, sample preparations and Chemistry making sure test and documentation are complete and accurate-GMP process inspections and completes documentation-Conducts review of final reports (GLP) and/or CofA for reviews and standard and custom studies-Conducts GMP batch record reviews-Conducts Protocol reviews-Train new auditors-Assists in internal audtits as needed

-Conducts GLP critical phase audits in Genotoxicology, In-vitro, In-vivo and Histology, In-life studies, sample preparation and Chemistry making sure test and documentation are complete and accurate. -Conducts final report (GLP and GMP) and/or COA for reviews for standard studies and completes documentation.-Ensures compliance to applicable FDA and ISO regulations requirements

-Audit/reviewing of executed and master batch records and finished product release-Represent company interests through product review and release of contractor records-Responsible for Quality Assurance activities associated with marketed product support teams including ensuring the accuracy and integrity of all data. -Responsilbe for problem solving that arises in manufacturing and packaging areas.-Audited internal documents for Annual Product Quality Reports-Facilitated the handling and investigation of customer compliants-SOP administrator- maintained master SOP book and distribution of SOP's-Maintained the Supplier Corrective Action Request, working with outside vendors to ensure that they were aware of the problems that occurred with the product.- In charge of the label committee- set up meetings with label committee, worked with outside vendors to ensure that the redline proofs were correct and up to standard. -Assisted in writing labeling specifications