- ThermoFisher Scientific (Greenville, NC)
- …reviews, documents, and communicates test results. **Key Responsibilities:** + Lead the validation of test methods for pharmaceutical raw materials and finished ... Perform daily instrument calibrations/verifications as required. + Write and complete validation protocols in accordance with regulatory guidelines + Review and… more
- Novo Nordisk (Clayton, NC)
- …for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our ... 6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + Employee… more
- Lilly (Concord, NC)
- …and site teams, MES System Engineer will ensure compliance with validation requirements, and proactively address technical, operational, and business challenges. ... and implement the appropriate technical solutions. + Ensure project and/or validation documentation is maintained during lifecycle & release management. + Evaluate… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management ... trends, and propose process improvements. + Support process characterization and validation activities (PPQ) for downstream processes executed at CDMOs. + Evaluate… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …GxP, FDA, EMA, and other regulatory bodies. + Lead the development of validation strategies and documentation to support compliance efforts. **Integration with SAP & ... FDA 21 CFR Part 11, and other applicable standards. + Partner with Validation teams to develop and maintain validation documentation, including validation… more
- Sumitomo Pharma (Raleigh, NC)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and… more
- ThermoFisher Scientific (Greenville, NC)
- …The Staff Quality Control Environmental Monitoring Engineer will coordinate the validation environmental monitoring (EM) programs within our pharmaceutical ... Division (DPD) Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in… more
- ThermoFisher Scientific (Greenville, NC)
- …Coordinator ensures compliance with data integrity standards at the pharmaceutical manufacturing site by providing administrative and operational support within ... Integrity program activities. + Works with QC laboratories, manufacturing, QA, IT, and validation teams. + Ensures tasks and documentation are aligned with GMP, GDP,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …a drug product that is safe for human use. + Executes commissioning and validation activities associated with a new building. This job description is intended to ... a community college or + High school education and 1 year pharmaceutical , chemical, and/or production manufacturing experience in a regulated industry (FDA, USDA,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …compliance of upstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities ... trends, and propose process improvements. + Support process characterization and validation activities (PPQ) for upstream processes executed at CDMOs. + Evaluate… more
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