Quality Control, Specialist

Job description

Job Description Summary At Novartis, we are reimagining medicine to improve and extend people’s lives. The Specialist, Quality Control, assists and supports the organization with compliance and ongoing preparation, testing and monitoring conformance to established quality processes and standards for manufacturing and production. #LI-Onsite Shift: 1st Location: Durham, NC: This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Job Description: Key Responsibilities: - Responsible for directing and executing method transfers/verifications and assisting in execution of bioanalytical (BAL) analysis for cGMP release and characterization testing using techniques including but not limited to CE-SDS, SDS-PAGE and CZE methods. - Supports BAL assay onboarding/execution, including drafts and maintenance of QC SOPS, forms, protocols, reports, Analytical Master Plans and change controls. - Reviews and approves data for reports and specification compliance; supports and leads resolution of nonconformances (SSFs, deviations, OOS/OOT/OOE investigations) - Assist with enrollment of vendors, ordering re...