- Lilly (Durham, NC)
- …the safe operation of highly automated equipment producing products of the highest quality serving Lilly patients worldwide. In addition, Line Leader will also be ... area. + Provide leadership on manufacturing floor ensuring high level of safety, quality , and productivity to maintain reliable supply of products to patients. +… more
- Merck (Wilson, NC)
- …defined such that vaccines filled at the Wilson site consistently meet critical quality attributes + Act as or support technical subject matter expert(s) during ... and implement robust Corrective Action and Preventive Actions and author quality investigations for any applicable process related compliance discrepancies noted… more
- Honeywell (Charlotte, NC)
- …**Focus Areas** Technology transfer streamlining, batch execution and recipe management, quality management systems, regulatory compliance (GMP, FDA , EMA), ... in addressing critical challenges including technology transfer, batch execution, quality management, regulatory compliance, and operational efficiency. **Key Responsibilities**… more
- ThermoFisher Scientific (Greenville, NC)
- …digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities ... not limited to PV operations, training development, business objectives, quality initiatives and management, process improvement, compliance, and innovation. Applies… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …per approved Manufacturing Directions while maintaining compliance with all job-related SOPs + Quality + Ensure that all batch paperwork is completed in an accurate, ... deviation analysis, CAPA actions and other process equipment related quality concerns + Maintain all work areas in a...and documentation to record data manually or through identified software applications. + Safety + Comply with all safety… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …utilize SOP and documentation to record data manually or through identified software applications. + Operate high speed manufacturing equipment, in some cases highly ... per approved Manufacturing Directions while maintaining compliance with all job-related SOPs Quality + Ensure that all batch paperwork is completed in an accurate,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …acceptance testing. + Field supervision of contractors during construction to ensure safety, quality , and schedule. + Work as part of a multidiscipline team to ... utility systems. + These new utility systems are to support the FDA licensed blood fractionation, purification, and filling operations. Pharmaceutical experience is… more
- Cambrex High Point (Durham, NC)
- …customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities ... Together with our customers, we aim to improve the quality of life for patients around the world. Start...and execute compendial methodologies + Strong understanding of current FDA and cGMP regulations + General knowledge of chemistry… more
- Fujifilm (Raleigh, NC)
- …and providing our customers with timely responses. + Works on 3rd party hardware, software , and network related issues that are sold or supported by FUJIFILM. + ... the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job… more
- Sumitomo Pharma (Raleigh, NC)
- …specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data presentations and TFLs. ... Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus...proficiency in BASE SAS and R, or other statistical software is advantageous + Effective verbal and writing skills… more