SAS Stability Coordinator
Core
Managing pharmaceutical stability programs, data, and regulatory documentation for sterile injectable products.
Role type
Stability Coordinator
Builds
Stability data and regulatory reports for FDA/Health Canada markets
Domain
Pharmaceutical manufacturing (sterile injectables)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
stability program management, LIMS, protocol development, data review, inventory management, vendor coordination, APQR preparation, regulatory audit support, troubleshooting environmental controls
Preferred skills
none stated
Technologies
LIMS, Ennov, Microsoft Office, AX, CARL
Responsibilities
Manage stability program schedules and initiate studies; Log and receive stability samples; Prepare and update stability protocols and specifications; Review stability data and trends; Manage stability chambers and investigate excursions; Support Annual Product Quality Review (APQR) and regulatory audits; Coordinate with vendors and manage work orders; Provide training to staff
Seniority
Mid-level, hands-on IC
