The R&D Documentation Coordinator will facilitate and coordinate all aspects of the R&D Documentation process. The position also requires the maintenance of electronic and manual archives.
Main Job Duties:
Maintain filing and storage area for all R&D Study Records, Lab Notebooks, Design History Files, and Histology slides
Assign R&D Study numbers
Assign memo numbers
Assign Lab Notebooks and perform routine Lab Notebook audits
Update and maintain electronic and manual archive of lot Device History Files
File and retrieve documents and files as needed.
Prepare documents and lab notebooks for Off-Site storage
Support the creation of new and revisions to existing documents (i.e. policies, procedures, work instructions, and forms).
Support of records related issues during internal and external audits
JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
Education and Experience:
• HS Degree
• Essential knowledge of MS Office (Word/Excel)
• 1-2 years experience working in a documentation control environment
• Good communications skills and ability to multi-task and work independently
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
• Knowledge of electronic document control systems
• Previous experience to include medical device/pharmaceutical regulated companies