Summer Intern position: June - August 2019

American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.

Nature and Scope

The Intern, Computer System Validation will assist the GxP Computerized Systems team (in the Quality department) in daily activities. They will have the opportunity to learn about the FDA's regulations governing User Access, the validation documentation requirements for a project, and the importance of remediation methodology.

Essential Duties and Responsibilities

• Remediate User Access forms with various systems and provide reports on findings
• Verify the projects available in SharePoint contain all required documentation, and remediate if not
• Support CAPA (Corrective Action Preventative Action) status - acquire from owners, update log
• Provide assistance to Inventory Log remediation efforts
• General administration for the department

Qualifications and Requirements

• Undergraduate student pursuing a degree in Business or similar
• Strong computer skills
• Previous work experience in an office environment, a plus
• Attention to detail

We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

##Job Category: Quality Affairs##