In this role, the selected candidate must have an excellent understanding of 21 CFR Part 11, ICH standards, EMEA, GLP, GCP, GMP, GDP regulations, GAMP Methodologies and general software development standards.
This position will be part of the CMO Quality group responsible for representing Shires Quality function during qualification and validation activities related to cold chain/controlled temperature shipments and CMO drug substance & product manufacturing / packaging operations and will involve.
This position is a responsible subject matter expert for QC activities including leading investigations, method validations, method transfers (internal and external), and other GMP activities in support of the QC Microbiology group.
In this role, you will review and approve manufacturing and analytical deviations, out of specification investigations and material non-conformance. Compile data, prepare and review trends. Identify areas of concern and communicate to management.
In this position, you will perform general QC lab tasks including TGA, Carbon, pH, Density, Total solids, Karl Fisher, Titrator, Nitrogen Sorption, Particle Size, UV/Vis, Conductivity, ICP Atomic Emission, GC, and Liquid Chromatography (HPLC, UPLC, SFC and LC-MS).
In this role, the selected candidate will act as a QA representative on associated projects related to Quality laboratory operations; ensure clear communication on issues and timely escalation as applicable.
In this role, you will support the organization in monitoring of the compliance of laboratory testing, manufacturing, and clinical research and ensuring continued effectiveness of the QMS according to CLIA, CAP, HIPAA, GLP, GMP, and QSR requirements.
The Sr. Quality Systems Quality Assurance Associate is responsible for assisting with the day to day operations related to the Quality Standards program and data analytics within the Quality Systems department.