9 months contract
Essential Duties and Responsibilities
• Directly responsible for ensuring documents submitted to Quality are compliant to company procedures, regulatory requirements, and the quality manual.
• Performs project review and audit of Device History Files (DHF's) and technical files including:
o Stability protocols and reports
o Summary of Safety and Performance reports
o Risk Management plans, reports, FMEAs
o Post-Market Surveillance plans and reports
o Performance evaluation plans and reports including scientific, clinical, and analytical documents.
o Product composition reports
o Sensitivity and specificity/Repeatability and reproducibility reports
o Specification reports
o General Safety and Performance Requirement reports
Preferred: Bachelors degree in any life science, GMP, Pharma industry experience
At least 1 year of experience
Ideal candidate has reviewed docs in a GMP setting or worked in a quality role in a GMP setting.
Energetic, quick learner, excellent attention to detail
Technical documentation for product design - PLUS