- Lilly (Concord, NC)
- …accurate, and used effectively in compliance with quality standards and regulatory requirements. + Oversee MRO (Maintenance, Repair, and Operations) activities, ... calibration schedules for all critical equipment, ensuring compliance with regulatory standards and internal quality requirements. + Coordinate with cross-functional… more
- J&J Family of Companies (Wilson, NC)
- …and guidelines including FDA , EPA, OSHA, DEA and TSA. + Ensures regulatory and job training remains current by promptly completing required training + Comply ... that automated systems are fit for intended use and follow applicable regulatory requirements (eg cG(a)MP) and company manufacturing standards throughout the entire… more
- Biomat USA, Inc. (Greenville, NC)
- …Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance. . Maintains oversight of center training program by ensuring ... . Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and… more
- CREO (Durham, NC)
- …platforms and systems (eg, ERP, CRM, QMS, CTMS, eTMF, LIMS) and associated GxP/ regulatory compliance (GxP, 21 CFR Part 11, FDA guidelines). + Well-developed ... technology programs. + Deep understanding of the business, technology, and regulatory challenges in growth-oriented life sciences businesses - specifically medical… more
- Reckitt (Wilson, NC)
- …scope. + Ensuring dispensing and tank farm systems meet all relevant regulatory requirements, including company standards, FDA regulations, and state/federal EHS ... operational efficiency, and ensure asset reliability-all while meeting stringent regulatory standards. This position requires hands-on knowledge of automated… more
- Cambrex High Point (Durham, NC)
- …with approval * Responsible for ensuring compliance with cGMP and other regulatory guidelines. * Analyze information for technical correctness and accuracy * ... including organic chemistry. * Able to comply to SOPs and basic regulatory compliance * Working knowledge of scientific concepts, principles and procedures *… more
- HCA Healthcare (Asheville, NC)
- …technical and non-technical resources and operations to meet organizational and regulatory requirements. + Execute programs for staff hiring, orientation, training, ... conduct. Contribute to achievement of department goals for service, quality, regulatory compliance, financial performance, and patient and employee satisfaction. +… more
- Novant Health (Charlotte, NC)
- … regulatory entities including FACT, CLIA, NMDP, CIBMTR, and FDA . Responsible for qualification, validation, auditing of all critical processes,equipment, ... Novant Health. + Is a key member who ensures compliance with regulatory agencies, recommends an appropriate organizational structure and personnel plan for the… more
- Sumitomo Pharma (Morrisville, NC)
- …and external partners. Critical responsibilities include ensuring compliance with regulatory requirements, company procedures, and supporting the build-out and ... Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents. + Experience in tissue and cell-based… more
- Cambrex High Point (High Point, NC)
- …and deliverables + Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Analyze information for technical correctness and accuracy + ... TGA/DSC) + Able to comply to SOPs and have understanding of regulatory compliance + Working knowledge of scientific concepts, principles and procedures +… more