· Leading the team of Quality Engineers on manufacturing issues, real time to facilitate in determining product impact and immediate corrective actions.· Leading the training activities for quality techniques, testing products, and compiling/evaluating statistical data to monitor quality levels.· Responsible for activities related to Quality Assurance support of operational activities for Shop floor support for: Manufacturing, Packaging, Facilities and Materials management.· Work in collaboration with Operations, Technical Services, Supply Chain, Deviation Writers and QC Laboratory to ensure that quality in the organization is consistent in application by proactively ensuring cGMP compliance to ensure the manufacturing of high-quality products. · Quality Management of GMP documentation: Change Controls, Investigations, CAPAs, Protocols and Reports and Standard Operating Procedures.· Review of process-related deviations, while assisting in root cause analysis and assigning of related Corrective and Preventative Actions.· Support Inspection(s); FDA, HPRA, Third Party and Corporate Audits, while being a change leader of remediation activities.· Quality Assurance representative for instituting MES and Electronic Batch records.

· Team leader and manager within the Quality Assurance Review and Release Team.· Reviewed and released the analytical data for all site wide material releases; API, Intermediates and Finished Product.· Coordinated third party laboratory special testing (for cause, method validation, etc.) and release with the laboratory and external sites to meet supply chain demands.· Performed as the Quality Control review and release point of contact for Affiliate injectable products tested at Mylan Pharmaceuticals Inc.· Developed and implemented work instructions on the use of LabWare © LIMS throughout the Quality Organization (QA & QC).· Performed as a site team leader on a cross functional, collaborative project consisting of; global quality, regulatory, and site quality for batch disposition during health authority remediation.· Participated in Back Room Support to facilitate health authority request during site inspections.

· Reviewed and released the analytical data for all site wide material releases; API, Intermediates and Finished Product.· Performed review and approval of validation documents including protocols and reports for laboratory equipment and method validations.· Communicated laboratory release information cross-functionally to ensure product flow to production and sales/customer service.· Liaison with Quality Regulatory Compliance to generate COAs in support of Regulatory submissions for compendial updates, purchasing changes, comment letter responses, etc.· chemist, quality control | mylan pharmaceuticals inc. | June 2013 – april 2015· Preformed HPLC and Karl Fisher analytical chemistry testing on drug substances and drug products.· Peer-reviewed and approved paperwork for HPLC Testing.· Participated in Right First-Time committee to help the lab prevent test execution errors, and to maintain a flow of the product from start to finish.

· Preformed analytical chemistry testing including composite assay, content uniformity, weight variation, dissolution, moisture analysis, and related compound testing utilizing HPLC and Karl Fisher instrumentation on drug substances and drug products.· Peer-reviewed and approved paperwork for HPLC Testing.· Participated in Right First-Time committee to help the lab prevent test execution errors, and tomaintain a flow of the product from start to finish.