- Alaka'ina Foundation Family of Companies (Camp Lejeune, NC)
- …is evaluated by observation and outcomes for effectiveness of operations and compliance with medical requirements and professional standards in terms of quality ... sponsors, etc. + Review new research protocols for consistency, completeness, and compliance with all DoD, BUMED, NMCCL, and other federal and applicable state… more
- BrightSpring Health Services (Charlotte, NC)
- …to market, and an industry shift from hospital delivery settings to lower-cost, high- quality alternative providers such as Amerita. As a core member of the Pharmacy ... compounding/clean room areas and related equipment are cleaned, sanitized and maintained in compliance with company policies and procedures, and USP 797 and USP 800… 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...of project tasks and deliverables + Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Analyze… more
- Stantec (Raleigh, NC)
- …us create buildings that matter to our world. Together, we are enhancing the quality of life globally through design. Join us and design your place with Stantec. ... related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …specialized equipment that directly impacts site manufacturing operations and product quality . The role involves championing failure root cause analysis and actively ... designed, support production in achieving output goals, and help deliver a quality product. Primary Duties: 1. Performs, documents, and improves procedures and… more
- ThermoFisher Scientific (Greenville, NC)
- …(ie new lines/processes) + Implementing standard methodology (ie ensuring understanding / compliance with updated Annex 1 - leading the transition and any risk ... of leadership experience required. + Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site. +...sterile lines) would be beneficial. + Familiarity with US FDA , EU Annex-1 and other regulations and guidance. +… more
- Catalent Pharma Solutions (Greenville, NC)
- …drug development. Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and ... committed to a Patient First culture through excellence in quality and compliance , and to the safety...entries are accurately documented and compliant with SOPs and FDA cGMP guidelines. + With minimal supervision, conduct setup,… more
- Mentor Technical Group (NC)
- …to plants and equipment. + Support maintenance and calibration functions to improve compliance and quality . + Provide expertise in troubleshooting and root cause ... 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
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lead development of the statistical analysis plan, ensure data integrity and quality of collected data and execution/programming of the statistical analysis plan.… more
- BioFire Diagnostics, LLC. (Durham, NC)
- … compliance with company policy and within the guidelines of bioMerieux's Quality System. Adhere to Regulatory requirements, including FDA , ISO, Legal, ... assigned categories to leverage opportunities and innovation. Assist in the Quality Management System (QMS) audits/site supplier visits to ensure the relationship… more