R&D Documentation Coordinator
Edison-New Brunswick Metro Area, NJ
The R&D Documentation Coordinator is responsible for control, security, accessibility, and timeliness of R&D documents that may be used by or useful to the Team, such as Studies, Memos, Notebooks, Design History Files, policies, procedures, and templates.
The position also requires the maintenance of electronic and manual archives. Creativity with solving archival issues, new procedures or bettering existing procedures.
HS Degree or equivalent. An Associate or Bachelor s degree is preferred.
Ensure the security, accessibility, and proper distribution of R&D documents
Maintain multiple R&D documents and document management systems
Manage R&D documentation through the document Life Cycle
Retrieve and send electronic Documents as requested.
Assist with Document delivery during Internal and External Audits
Assign Document Numbers according to relevant process
Record, track, and file Histology Slides (Electronically and physically)
Support the creation of new and revisions to existing documents (i.e. policies, procedures, work instructions, and forms)
Update and maintain electronic and manual archive of Design History Files (DHFs)
Create and implement new ideas and methods for document retrieval and storage, electronically and physically.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
3-5 years of experience working in a documentation control environment
Good communication skills, oral and written
Knowledge of electronic document control systems
Previous experience to include medical device/pharmaceutical regulated companies
Ability to multi-task and work independently with minimal supervision
Proficient in the use of Adobe and MS Office (Word/Excel/PowerPoint), copiers and scanners
Knowledge of GLP requirements and procedures
Ability to adapt to and embrace change