- Actalent (Greenville, NC)
- …+ Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines. + Conduct thorough investigations to ... enhance knowledge and skills related to deviation management and quality assurance. Essential Skills + Bachelor's degree in a...a related role. + Knowledge of regulatory requirements (eg, FDA , EMA) and industry standards. + Strong analytical and… more
- Fujifilm (Holly Springs, NC)
- …a GMP environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. * High level of ... QA Engineer, DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance...operational readiness. The QA Engineer, DSM is responsible for quality assurance oversight of day‐to‐day activities and resolution or… more
- Lilly (Concord, NC)
- …This individual must ensure cross functional collaboration between operations, engineering, quality , supply chain and maintenance to meet key metrics and ... the area. Above all else, the role will lead by example with a safety first, quality always approach. As a site leader and expert at our growing site, you will have… more
- Fujifilm (Holly Springs, NC)
- …regulated environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. **Preferred ... Overview** The QA Engineer, DSM Operations is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes… more
- Kelly Services (Clayton, NC)
- **Position Title:** Quality Control Environmental Monitoring Manager **Location:** Clayton, NC **Schedule:** Monday - Friday | 8:00 AM - 5:00 PM **Salary Range:** ... Summary:** This role is responsible for the comprehensive management of the Quality Control (QC) Environmental Monitoring (EM) laboratory. The position oversees … more
- Lilly (Durham, NC)
- …of leaders, you'll influence and implement our organizational agenda, business priorities, and quality objectives to drive success down to the floor level. Join us ... ensuring adequate resources are in place for successful implementation. + **Safety and Quality Culture:** Lead by example in building and driving a culture of safety… more
- ThermoFisher Scientific (Greenville, NC)
- …of EM techniques, equipment, and regulatory requirements. + Familiarity with GMP , FDA , and other regulatory standards for pharmaceutical manufacturing. ... to commercialization. **How Will You Make an Impact** The Staff Quality Control Environmental Monitoring Engineer will coordinate the validation environmental… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …learning and mastering manual and automated testing procedures conducted within an FDA regulated GMP /GLP environment. Performs biological testing of moderate to ... preparation, in-process testing, result calculation, performing IV injections, as well as quality control of assays and equipment. Candidates for the position must… more
- Charles River Laboratories (Research Triangle Park, NC)
- …responsibilities include: + Review, comprehend and comply with all SOP's and quality assurance standards pertaining to specific areas. + Support research staff in ... while performing daily animal health observations, animal husbandry duties to maintain quality and health of research animals, to include: perform daily water bottle… more
- Honeywell (Charlotte, NC)
- …and recipe management, quality management systems, regulatory compliance ( GMP , FDA , EMA), manufacturing analytics, digital transformation initiatives, ... in addressing critical challenges including technology transfer, batch execution, quality management, regulatory compliance, and operational efficiency. **Key Responsibilities**… more