Offsite Systems Documentation POC Specialist

Company seeks Consultant to provide biomedical technology expertise and project management skills to plan, implement, lead, and finalize the Systems Documentation Project for Core 1.

Duties will include:
- Developing process for succinctly and accurately documenting Standard Operating Procedures (SOP) for conducting laboratory evaluation of diagnostics, and for field evaluation of diagnostics.
- Actively engaging with Core 1 Team during development and documentation of evaluation procedures, and incorporate team feedback.
- Drafting and finalizing systems documents for use in the lab and field.

This position is expected to last 30 days.

Candidates must have:
Strong writing and analytic skills, attention to detail. Experience designing Design Control systems for in vitro diagnostic devices. Experience writing Design Control system documents. Clinical Research Professional Certification (CCRP) preferred but not required. Familiarity with diagnostics and experience writing technical reports and/or standard operating procedures is highly desirable. Experience with ISO 9000, ISO 9001, and/or ISO 13485 is desirable.

Required Experience
Bachelors degree in Biological Science, Engineering, Public Health, or a closely related field or an equivalent combination of education and experience, is preferred.

Compensation: Consultant rates; DOE 

Employer Posted:Thursday, June 25, 2009