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 inspection ready
Maintain product quality complaint handling (documentation, coordination, investigation, resolution, closeout) and investigation processes for R&D and commercial products in compliance with regulatory requirements (21 CFR 210, 211) and internal procedures
Escalate critical complaints, quality events, trends to senior management timely, per procedure
Participate in the qualification, onboarding, and product training of call center for handling of commercial product quality complaints
Support Annual Product Reviews as they relate to Quality System records. Support any potential stock recovery/recall, and/or field alert/field correction activities, if needed
Work with internal stakeholders to establish and maintain feedback systems and other post-market surveillance processes
Participate in internal audits and health authority inspections as required for the scope of work associated with this role
Support GMP quality systems by driving regulatory compliance in accordance with applicable regulations and business objectives
Additional Quality projects and responsibilities may be assigned based on the business needs of a growing organization