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