Senior Associate I - Quality Assurance Operations

Senior Associate I - Quality Assurance Operations. Accountable for execution of the QA on the Floor program; performs routine walkthroughs of the Manufacturing Area partnering with manufacturing on Quality best practice implementation and troubleshooting; provides direct quality support for routine manufacturing operations; responsible for issuance of controlled documents for production (Batch Production Records, Product Labels, forms); reviews batch records, test data, environmental monitoring data, and logbooks for production of solutions and columns used in the manufacture of bulk drug substance; performs release of produced solutions and columns; assists with inspection of final product containers; supports shipment of finished products; reviews facility and equipment records in support of GMP operations; responsible for control and management of Cell Bank inventory; notifies Management of potential quality or regulatory issues; performs or supports other tasks to maintain product quality and site CGMP compliance; files and maintains controlled documents; other duties as assigned.