Pharmaceutical Statistician (QE)
Our client is in the pharmaceutical industry and looking for someone to come on-site and handle statistical document writing and root cause analysis for multiple locations. They are in the middle of a tech transfer to a different location and need a statistician that can evaluate out of spec batch records from a process standpoint.
The statistician will be working out of Philadelphia but will help coordinate and work with statistics and document writing for their other locations. The consultant will be responsible for evaluating manufacturing batch records from an oral solid dosage facility, review, and perform root cause analysis on their raw materials. For this reason they should be familiar setting parameters from a formulation perspective.This person must have experience working with Minitab software as they will be using it to receive lab data. They should be comfortable compiling the data and writing statistical summary reports. A pharmaceutical QE background is required for the root cause analysis they will be performing on the data being pulled from the system. This is a hands-on role and the consultant must have experience writing annual product reviews as well as continuous process verification.
- Pharma Exp and Root Cause Analysis
- Oral Solid Dosage
- Process Validation-from development perspective
- Exp with Minitab (Highly Preferred)
- Hands-on Statistical Document Writing
Job Type: Contract