Stability Coordinator, Quality Control 10/11/2017
San Diego, CA
JOB DESCRIPTIONAPPLY The Quality Control Stability Coordinator is responsible for the management of stability programs to support the commercial programs at PaxVax.
Authors stability protocols and reports.
Authors IND and annual report stability sections.
Recommends new stability programs for products in compliance with ICH guidelines.
Schedules and coordinates the pulling of all stability samples with the QC laboratory.
Reviews analytical data for completeness and trending.
Complies stability data for trending, reporting, and archiving.
Aids in the outsourcing of stability samples to contract laboratories for testing.
Aids in OOS and OOT investigations and recommends corrective actions.
Performs trends analysis and presents to key departments.
Responsible for transfer of paper-based stability program to LIMS system.
Other responsibilities, as required.