Sr QA Material Supplier Specialist (Qualification)

Job description

The QA Material Supplier Specialist - Qualification implements activities within the material qualification program to support the utilization of raw materials in Drug Substance and Drug Product Manufacturing. In this role, a typical day might include the following: Performing activities associated with qualification of raw materials such as, development of sampling and testing protocols, review of test data, drafting summary reports, etc.; execution of sampling activities may be on the floor Representing Quality Assurance in support of deviations, change controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution Provides guidance internally and externally to ensure quality and regulatory expectations are met in relation to material quality standards Support and/or approval of SCARs (Supplier Corrective Action Requests) Working with Suppliers to obtain documentation to support closure of SCARFs (Supplier Corrective Action Request Follow-Ups) Reviews/approves Drug Product Component Supplier-specific documentation such as Approved Supplier Approvals and TSE/BSE Assessments Provides support to relevant departments in the utilization of Dr...