Serve as QA representative for commercial finished goods and external manufacturing partners. Represent Finished Goods Quality Operations at routine internal meetings and external contract manufacturers and for commercial production.
Oversee quality aspects of commercial finished goods specifications, qualification and validation, drawings, artwork, label, serialization, and packaging operations at CMOs for global commercial supply and ensure compliance to internal standards and regulatory requirements for US production.
Review and approval of content within manufacturing partner and Alnylam Label and Pack documents, including BOMs, MPRs, Product Specifications, and Variable Data. Ensure proper archival of manufacturing partner documentation in Alnylam s document management system. Manage Quality Records (deviation, capa, change control, serialization excursions, issue escalation) as it relates to commercial finished good assembly, label, and pa...