Senior Quality Assurance Specialist

Role Summary

The Senior Specialist will be responsible for the processing and maintenance of the Quality System records supporting GMP activities. These records include quality events, deviations, investigations, CAPA, change controls, and complaints for R&D and Late Phase/Commercial GMP activities. This role reports to the Senior Manager, Product Complaints & Quality Systems and supports Global Product Quality and cross-functional partners to assure robust QMS records and inspection readiness. This position will also receive, document, investigate, resolve and respond to product quality complaints and other post-market feedback.

Key Responsibilities

• Maintain and review Quality Events, Deviations, Investigations, CAPAs, Change Control, and Product Quality Complaints for R&D and Late Phase/Commercial GMP activities
• Review investigations to assure they are robust, properly documented (including root cause analysis, product quality impact assessment, CAPA), and adhere to procedures
• Write internal/vendor Change Controls, Quality Events, Deviations, Investigations, CAPA, and Product Quality Complaints and ensure they are properly documented in Veeva and insp...