At Shire, we are proud and grateful to employ military veterans and thank them for their contributions to our company and our country. See where your military experience can play a role at Shire by using our military skills translator job search tool below:
Personal Attributes Required: Communication Interpersonal Awareness Results Driven Individual working Ability to Learn Initiative Critical Information-Seeking Concern for Standards Analytical Thinking Thoroughness Independence Team Player Time Management Adaptability Flexibility Efficiency Orientation Attention to Detail Problem Solving
Responsibilities: Process Certificates of Analysis and Declaration Statements requests from Sales/Warehouse. Extensive research, follow-up, and communication with manufacturers. Process T3 documents in accordance with DSCSA regulations. Assist Regulatory Manager with interpretation of DSCSA regulations. How to handle, process and maintain documentation for TSE requests. Assist in any daily, weekly, monthly, or annual audits as directed. Maintain department spreadsheets and records in detailed, up-to-date, and orderly manner. Knowledgeable with DEA audit requirements and regulations, to assist with internal monthly quality and inventory audits. Work with Assistant Regulatory Manager on Technical Inquiries, Quality Complaints, Recalls, and other regulatory documentation as needed. Knowledgeable with the Mississippi Board of Pharmacy regulations for Wholesale Distributors. Create and maintain company forms and documents, following company policy and procedures. Assist in research, approval and maintenance of new and current vendor/supplier files. Review emails daily with Regulatory team to determine the workflow of items. Knowledgeable using Outlook and Server files for record retention and document storage. Process requests for MSDS certificates, Shelf life inquiries, Stability requests and label or formulation changes. Research, record and document. Maintain documentation as per governing regulations. Maintain knowledge of all Regulatory agencies regulations. Backup other Regulatory staff; to fill in during vacations, absences, increased workflow etc. Any other duties assigned by your Manager.
Qualifications and Experience Needed: Graduate, High School Diploma or GED. Excellent oral and written communication skills. Proficient with Microsoft Office Suite, with concentration on Microsoft Excel. Ability to multitask. Attention to detail and good organizational skills. Strong problem solving and analytical skills. Self-starter and ability to work independently. Positive attitude and strong work ethic. Ability to effectively work in a team environment, maintaining group morale and mutual respect. Other duties that may be reasonably required from time to time by company managers, including delegated duties during the absence of colleagues.
Send resumes and/or cover letters to vroley@mdes.ms.gov and MDES Pascagoula will forward to the company.