Specialist, Quality Control - Physical Chemistry

Job description

Band Level 3 Job Description Summary: 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. Location: - This position will be located in Durham, NC and will be an On-Site role. - Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Key Responsibilities: - Execute routine and non-routine analysis for cGMP release and characterization testing using techniques including but not limited to chromatography (HPLC, UPLC), AUC, SEC, compendial assays (pH, Conductivity, Osmolality), electrophoresis (CE, Western Blot) and assist with data review. - Execute method verifications/transfers as required for various projects. - Assist with enrollment of vendors, ordering reagents and consumables for new assays. - Initiate all paperwork (LIMS, SOPs, assay forms) for testing and transfers of methods for projects. - Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with interna...