Sr. Specialist CSO Documentation and Training

Sr. Specialist, CSO Documentation and Training Department/Division: CSO-NBR Compliance & Business Operations This role is 100% Onsite in New Brunswick, NJ Work Schedule: Mon - Fri, Business Hours This role is a key role in the CSO organization to ensure day-to-day compliance within the organization as it pertains to GxP documentation and training. This role will work with multiple departments across Product Development to communicate effectively for all Training and Documentation related issues. The position manages the controlled documentation (Standard Operating Procedures, Forms, other controlled documents, etc.) for CSO NBR Manufacturing along with Training. Responsibilities and Tasks: Develop training curriculum, evaluate/monitor training materials, record training activities and program effectiveness. Conduct integrated training needs assessments, organize, and develop training procedure guides and/or course materials, and provide trainings onsite or remote. Work with CSO departments to ensure training curriculum is appropriate and focused based on job functions. As a Content manager of various PD Electronic Document Management systems (i.e., PDHQ, Corporate Docs, Docman), create, review, control and maintain CSO controlled documents related to clinical manufacturing activities. Provide support for periodic review workflows, CAPAs, maintenance of CSO JDs, CVs, etc. Process/Manage GMP documents using electronic systems according to Global/Site procedures. Manage creation, review, and process of CV, JDs, and Signature Logs, as required. Generate Metrics for Training and Documentation team. Perform Quality investigations including accurate root cause analysis and ensure timely completion of investigations. Support continuous improvement efforts. Ensure Training and Documentation data are properly captured, stored, archived, available, and maintained in an audit-ready state. Assist with the training programs as needed such as 'train the trainer' programs. Identify and escalate technical and/or business issues promptly; must be able to solve routine issues independently. Complete routine Documentation and Training tasks with little or no supervision. Disclaimer: The responsibilities listed above are only a summary and other responsibilities may be added upon business needs. Experience Required: Must have experience with Learning Management Systems (i.e., SuccessFactors, Compliance Wire, etc.) and QMS Documentation Systems (i.e., CDMS, EDMS, Veeva, etc.) Advanced knowledge of Microsoft Office (Excel, Word, SharePoint, etc.) Experience in Deviation writing, Change Controls, etc. Excellent attention to detail with the ability to work accurately and independently in a busy demanding environment. Strong collaboration and communication skills. Ability to successfully work within strict timelines showcasing excellent organizational and time management skills. Ability to negotiate and act as a mediator between functional areas while meeting timelines and paying attention to details. Must have a good work ethic, able to work independently as well as with others on the team. Education: Bachelor's Degree Required; Preferred if the candidate has over 8 years of experience without the degree. Physical Requirements: Must be able to lift 1 to 5 pounds, sitting, standing, walking area as required. #J-18808-Ljbffr