Job Details

  • Title: CMC Documentation Specialist
  • Code: RCI-29686-1
  • Location: New Brunswick New Jersey (NJ) 08903
  • Posted Date: 11/08/2019
  • Duration: 6 Months
Talk to our Recruiter

  Job Description

Summary of Position:

  • This position is part of CMC documentation and stability (CDS) group as a support function to the CMC documentation reps.
  • The selected candidate will provide PRISM/CARA support, creating workflow and document upload on electronic document management systems and SharePoint sites.

Major Duties & Responsibilities:

  • Provide support for CDS group by uploading documents on QUMAS, and DocMan
  • SRC specialists role supporting CARA authoring ensuring documents are PRISM compliant
  • Create and maintain model document templates for analytical and stability functions.
  • Maintain the CMC & Stability group and Development Specification Committee (DSC) SharePoint sites and manage the specification routing and approval for drug substance, drug product, excipient and packaging component.
  • System administrator for QUMAS, DocMan, and Trackwise change control notification to support ASO (NBR and Moreton sites).
  • Maintain records management for Quality related documents.
  • Ability to manage multiple projects simultaneously and to plan and deliver the required documents on the due dates
  • Works independently in a team setting and is flexible in a changing environment.
  • Demonstration of good interpersonal skills, including good communication with supervisors and co-workers.

Education/Experience/Knowledge:

  • Bachelor’s Degree in Biology, Science, Mathematics or related field
  • At least 2-4 years of relevant experience.
  • Proficient in Use of Electronic Systems: Microsoft Office, PDLIMS, and QUMAS
  • Experience with Core template preferred.
  • Experience authoring with templates, tables and graphics