Specialist, Quality
Core
Execute stability strategies and protocols for pre-commercial and commercial stability studies of vaccine and pharmaceutical products.
Role type
Specialist, Quality (Stability)
Builds
Stability studies for vaccine and pharmaceutical products
Domain
Pharmaceutical / Biologics / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP Compliance, Chemistry, Biology, Data Analysis, Deviation Management, Documentation Review, Laboratory Information Systems (LIS), Quality Auditing, Quality Control Systems, Quality Inspections, Pharmaceutical Sciences
Preferred skills
Experience with vaccines, biologics, and/or devices, Working knowledge of analytical methods and manufacturing processes
Technologies
Laboratory Information Management System, Microsoft Word, Excel, statistical software applications
Responsibilities
Manage stability studies including sample handling, receipt, labeling, chain of custody, protocol creation, study builds, and closeouts; Collaborate with partner sites and labs to coordinate sample shipment and receipt; Review annual stability reviews for accuracy; Address and respond to product or project inquiries; Maintain GMP documentation per company policies; Support deviation management and implementation of corrective actions; Respond to early warning limit excursions; Author or revise local Standard Operating Procedures
Seniority
Individual Contributor, Specialist level