Nature and Scope The Logistics Specialist is responsible for administrative, quality management, process improvement, and technical tasks associated with supporting the Logistics department. The Logistics Specialist will assist in ensuring any non-routine events associated with the manufacture and/or distribution of safe, pure and effective sterile pharmaceuticals are investigated and documented in accordance with company SOP’s, policies and cGMPs. This position will be responsible for assisting in producing investigation summaries, data compilation and evaluation, impact assessment, root cause analysis and corrective/preventative actions. This position will also review and develop documents, supply requisitions, tracking and processing of invoices, project specific tracking, generation of process improvement efforts and performance metrics of Logistics department. Essential Duties and Responsibilities Draft processes for CAPA, Change Controls, Events, Deviations and Investigations within our Quality Systems. Drafting and completing SOP’s in Veeva Vault Quality systems Assisting in investigations associated with deviation, events and investigations. Assist in generating and reviewing departmental SOP’s and leads department in specific training. Ability to interface with front line operators and upper management Periodically summarize and present on-going process and performance metrics. Assist in ordering and maintaining department supplies. Assist in shipment tracking and in-transit issue resolution with providing proof of delivery when needed. Maintain address file for Pitney Bowes shipping system. Administrative support for the Logistics Department. Maintain confidentiality of all sensitive information. Education Requirements and Qualifications High School or GED equivalent, required. Associates or Bachelor’s degree, preferred. 3 years’ experience in logistics, preferred. Excellent writing skills. Technical writing experience, preferred. Knowledge of process improvement methodologies. Experience using Veeva Vault and Trackwise or similar systems, preferred. Knowledge of Microsoft Word, Excel, PowerPoint, Access and other programs, preferred. Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Ability to work overtime as needed. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com. Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.