The R&D Documentation Coordinator III is responsible for control, security, accessibility, and timeliness of R&D documents that may be used by or useful to the Client Team, such as Studies, Memos, Notebooks, Design History Files, policies, procedures, and templates.
- 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.
- HS Degree or equivalent.
- An Associate or Bachelor's degree is preferred.
- 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.
- The position also requires the maintenance of electronic and manual archives.
- Creativity with solving archival issues, new procedures or bettering existing procedures.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Angie: firstname.lastname@example.org
ALPHA'S REQUIREMENT #19-01905
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE