- Mentor Technical Group (Monroe, NC)
- …activities. + Is responsible for overseeing work order activity compliance with respective regulatory requirements (ie FDA , DEA, OSHA). + Manage Work through the ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Honeywell (Charlotte, NC)
- …transfer streamlining, batch execution and recipe management, quality management systems, regulatory compliance (GMP, FDA , EMA), manufacturing analytics, digital ... critical challenges including technology transfer, batch execution, quality management, regulatory compliance, and operational efficiency. **Key Responsibilities** Lead and… more
- Cytel (Raleigh, NC)
- …with Bayesian methods preferred. + Ensure quality and compliance with internal standards and regulatory guidelines (eg, FDA , EMA, ICH). **Here at Cytel we want ... complex manufacturing data to ensure product quality, consistency, and regulatory compliance. **As a Principal Biostatistician, your responsibilities will include:**… more
- ThermoFisher Scientific (Greenville, NC)
- …to evaluate data, develop technical solutions, and make recommendations. + Knowledge of regulatory requirements (eg, FDA , EMA, ISO) and industry standards. + ... document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines. + Conduct product investigations and develop CAPAs. +… more
- GRAIL (Durham, NC)
- …diagnostic activities, ensuring consistency and compliance with relevant GCP, CLIA, FDA /IVDR, and other global diagnostic regulatory requirements. + Serve ... you'll collaborate cross-functionally to proactively manage both GCP and CDx regulatory risks, lead inspection readiness, and continuously improve quality standards… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …policy and within the guidelines of bioMerieux's Quality System. Adhere to Regulatory requirements, including FDA , ISO, Legal, Ethical, and bioMerieux-specific ... procedures. + Source a variety of materials, equipment, and services in accordance with prescribed purchasing regulations and procedures + Master markets related to assigned categories/commodities, with a focus on soft-services. Seek of opportunities that… more
- Fluor (Raleigh, NC)
- …medical devices, pharmaceuticals, or healthcare equipment. + Strong understanding of regulatory requirements, including FDA guidelines and ISO standards. + ... Strong understanding of BIM/3D design tools and other relevant design tools. + Excellent leadership and team management skills. + Effective communication and interpersonal skills, with the ability to collaborate across different teams and levels of the… more
- Novant Health (Winston Salem, NC)
- …independently while following department/program policies and procedures, as well as regulatory requirements (ex. FDA , FACT). + Administers pre-transplant ... conditioning chemotherapy regimens and pre-CAR T lympho-depleting chemotherapy. + Performs hematopoietic cell transplantation and cellular product infusions. + Maintains and cares for patient venous access used during apheresis procedure. + Monitors patients… more
- ThermoFisher Scientific (Greenville, NC)
- …understanding on evaluated processes. **Requirements** + Bachelor's degree preferred + Regulatory Authority Inspections Experience ( FDA , MHRA, HEALTH CANAD, ... field** + **Solid knowledge of and experience in GCP compliance, regulatory inspection readiness and study execution processes** + **Experience with CROs… more
- Transylvania Vocational Services (Brevard, NC)
- …staff, including food safety, sanitation, and continuous improvement. + Ensure compliance with USDA, FDA , OSHA, SQF, OU, and other regulatory bodies. + Act as ... Quality Management System across all TVS manufacturing sites. This role ensures regulatory compliance, drives continuous improvement, and promotes a culture of food… more