- 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
- Name:Vishal Trivedi
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 435
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.
- 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