Sr. QA Specialist, Raw Material Quality

Provide QA life cycle oversight over the Alnylam raw material management and related quality systems from drug discovery through to clinical and commercial operations. Provide support with vendor and material qualification activities for domestic and international suppliers of raw materials. Provide technical expertise around raw material management and warehousing including quality and compliance standards, testing, qualification, and release. Support internal/external audits and regulatory inspections, as well as supplier audits as needed. Assist in maintenance and evolution of Alnylam's raw material management quality systems and processes. Contribute to regulatory submissions, as appropriate. B.S. in applicable science or engineering field. 5+ years of experience in Quality Control and/or Quality Assurance is required. Established background in raw materials management. Hands-on experience processing quality records (deviation, change control, CAPA, etc.). Experience with overseeing and coordinating work with external suppliers/vendors. Working knowledge with CFR, ICH, Eudralex and USP/EP/JP. Excellent team skills, organization, and strong interpersonal communication skills (written and verbal). Ability to adapt to a rapidly changing environment. Proficient knowledge of common software (e.g., EXCEL, PowerPoint, Word, etc.).