Areas of Expertise Desired:
* Responsible for collection, analysis, interpretation, processing and presentation of numerical information relative to process validation in a cGMP /CBER regulated medical device manufacturing environment.
* Leads or participates in process FEMA and implementation and validation of appropriate process controls. Generates and analyzes control charts to identify irregularities and errors.
* Leads or participates in the development and implementation of statistical models and sampling plans for application in validation.
* Generates and analyzes control charts as part of periodic trend analysis and develops statistical reports with data interpretation as part of the validation lifecycle (validation, monitoring, and revalidation).
* Serves as a statistical analysis subject matter expert for assigned projects.
* Must be able to communicate statistical approach and analysis in an understandable manner to people with little or no knowledge of statistics.
* Bachelor's degree or Master's degree, in math, statistics or engineering, or equivalent combination of education and work-related experience, required.
* Master's degree, in math, statistics or engineering, preferred.
* Knowledge and experience in IVD, Pharmaceutical, and or Medical Device Industry; Industry Standards for Validation; Industrial Statistics, Ferderal cGMPs and QSRs, ISO 13485.
* Expert understanding of process FEMA, control charting and statistical process controls with a keen ability for identifying irregularities and errors. Must be able to communicate statistical approach and analysis in an understandable manner to people with little or no knowledge of statistics.
* Familiar with statistical packages like MiniTab.
* Excellent written and verbal communication skills with ability to multi-task are required.
State or Province