- 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
- IQVIA (Durham, NC)
- …expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use of Patient ... PCS projects with a regulatory component, and ensure we provide consistently high quality insights and content + Support billable projects as SME and/or study lead,… more
- CaroMont Health (Gastonia, NC)
- …operations manager, and section managers to coordinate activities of the Laboratory Quality Management Plan. Conducts monthly quality meetings. Coordinates and ... by College of American Pathologists, Joint Commission, CLIA, AABB, CMS, and FDA . Responsible for coordinating off site inspections in conjunction with College of… more
- Cole-Parmer (Raleigh, NC)
- …+ Demonstration of sound problem-solving skills and troubleshooting abilities + Adherence to quality systems with special regard to FDA , ISO 13485 and GMP ... as well as document generation and completion. Key Responsibilities: + Execution of quality system procedures + Proper execution of SOPs and work instructions for… more
- Cambrex High Point (High Point, NC)
- …our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Job Overview Come join our QA team ... Ensures compliance with company policies and SOPs as well as FDA and other applicable guidelines. Qualifications/Skills Fundamental understanding (experience is not… more
- Mentor Technical Group (NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: + Quality Professional with Manufacturing Process Audit and Batch Record Review… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... plan, execute, and supervise study oversight activities with guidance from Quality , Strategic Development Clinical Operations, and clinical execution team. Oversee… more
- Biomat USA, Inc. (Greenville, NC)
- …Manages the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and regulations. ... staffing/hours per labor efficiency standards/cost per liter (CPL) targets and Quality key performance indicators (KPI) goals. + Create appropriate organizational… more
- Biomat USA, Inc. (Kannapolis, NC)
- …donor center when the Center Manager is not present. + Collaborates with Training and Quality staff to ensure that training and quality goals are met. + Coaches ... in budget preparation and oversees facility to achieve production targets and quality goals at the agreed-upon cost structure. + Actively delegates, monitors, and… more
- Reckitt (Wilson, NC)
- …this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege. **Manufacturing** Our ... Our Manufacturing Excellence team help us improve the efficiency, quality and safety of our manufacturing operations, and our...Serve as automation SME and ensure compliance with GxP, FDA , EU Annex 11, and 21 CFR Part 11… more