GMPOperationalQualitySeniorSpecialist

**Job Description** ## **General Summary:** ### ### The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives. The role works with a high degree of independence to provide QA Analytical support for commercial product stability programs and executes routine tasks and activities in support of QA Analytical function. ### ### ## **Key Duties and Responsibilities:** ### ### •Provides QA review of the GMP data in support of commercial product stability as required. •Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function. •Represents QA Analytical on cross-functional teams as an experienced Quality technical resource as needed. •Supports quality oversight of Root Cause Analysis (RCA) and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. May approve investigations/CAPAs. •Supports stability impacting change control activities such as assessment, implementation, and closure. •Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reports. •Supports external stability program activities for commercial products such as internal/external protocol review/approval, data review/approval and study initiation. •Enforces Quality Agreements between CMOs/Suppliers and Vertex as applicable to stability study pulls, test initiation, data reporting and OOS/OOT management. •Identifies and facilitates continuous improvement efforts. •Identifies and communicates risks and assists with risk mitigation plans, where applicable. ### ## **Knowledge and Skills:** ### ### •Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting including knowl