- Sumitomo Pharma (Morrisville, NC)
- …be a key member of our growing Quality Operations team, and support the Quality Systems , Quality Control and Quality Compliance functions. The ideal ... and implementation of regulations, guidelines, company procedures, and standards for the SMPA Quality Management System . + Ensure a state of inspection readiness… more
- United Therapeutics (Research Triangle Park, NC)
- …resulting products can be adequately manufactured and tested and that compliance to quality systems procedures, regulations, and standards are achieved + Support ... process and specification reviews as necessary + Participate in, and/or lead, quality system , process and product-related decisions. Recommend and manage changes… more
- ThermoFisher Scientific (Greenville, NC)
- …Validation related deviations and discrepancies. + Process Validation (PV), Cleaning Validation , and Computer System related protocols and reports. + ... Office **Job Description** The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and… more
- BioFire Diagnostics, LLC. (Morrisville, NC)
- The Global Clinical System Engineer II is responsible for end-to-end product ownership and contributing to worldwide serviceability throughout the entire product ... + Manage and coordinate end-to-end technical investigations with Manufacturing, R&D, and Quality + Contribute to the Field Action process: contribute in audit… more
- GRAIL (Durham, NC)
- … Operations organization, responsible for executing, maintaining, supporting, and improving GRAIL's quality management system (QMS). This role's focus is on the ... of quality engineering concepts and principles in accordance with GRAIL's quality management system and regulatory requirements including ISO 13485, ISO… more
- Amgen (Holly Springs, NC)
- …preferably biotechnology, pharmaceutical, or related industry. + Educational background in Computer Science, Engineering, Information Systems , or others related ... transform the lives of patients while transforming your career. MES Application Owner - Systems Engineer **What you will do** Let's do this. Let's change the world.… more
- TD Bank (Charlotte, NC)
- …that will cascade throughout the organization. **Department Overview** The Compliance Quality Assurance (US) team is responsible for providing independent quality ... are complying with established policies, standards and procedures. The Compliance Quality Assurance Senior Analyst will execute these reviews. This role will… more
- Amgen (Holly Springs, NC)
- …Verification/Automation Check Out (IV/ACO) + Support QA partners in performing computerized systems validation in a GxP environment + Perform Data Integrity ... part of Amgen's plan to be a carbon-neutral company by 2027. **Senior Manufacturing Systems Engineer: Automation - DeltaV** **What you will do** Let's do this. Let's… more
- GE Vernova (Wilmington, NC)
- **Job Description Summary** **Job Description** Work on I&C Systems team with a focus on work planning, technical approach, design assurance, and execution ... and Electrical. + Coordinate across matrixed Engineering teams to develop I&C system architecture, analyze plant system requirements, operations and maintenance… more
- Truist (Charlotte, NC)
- …to conduct reviews through the joint design sessions. 8. Assist with executing system validation , preparing the organization for the transition, and ensuring ... disabilities to perform the essential functions. 1. BS/BA in Business, Management Information Systems , Computer Science or similar area. 2. 7+ years in… more