- Novo Nordisk (Durham, NC)
- …what matters. The Position Coordinate & drive implementation of science & risk-based validation . The incumbent will provide input to project team members through all ... & commissioning/qualification/verification. Subject matter expert for all NN corporate validation procedures. Perform revalidation on equipment/processes per approved timelines.… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …110 countries and regions. **Overview:** The Engineer I - Validation / Engineer II - Validation / Validation Specialist I / Validation Specialist ... requires a minimum of 2-4 years experience which can include Co-Op or internship **Sr. Specialist I** - Validation - Requires a BS/BA degree in STEM (Science,… more
- Novo Nordisk (Durham, NC)
- …department. Position will also be responsible for the production activities & validation . Ensuring relevant compliance issues are addressed & handled in close ... + Authority for product release + Quality oversight, review & approval of validation activities associated with projects, new systems, changes to existing systems &… more
- Fujifilm (Holly Springs, NC)
- …Compliance is responsible for partnering in the Quality oversight of the Quality Control area . The QA Specialist helps drive Quality oversight for the direction ... from project phase through operational readiness, and provides oversight of validation program execution for these processes. This role collaborates with other… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The QA Specialist , Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This ... role provides oversight of validation program execution for these processes and systems to...with a focus on consistent policy administration. The QA Specialist , Drug Substance Manufacturing (DSM) ensures QA oversight of… more
- CenterWell (Raleigh, NC)
- …our caring community and help us put health first** The EMR Integration Specialist performs end-to-end planning, analysis, and validation for data migration ... requires an in-depth evaluation of variable factors. The EMR Integration Specialist works within specific guidelines and procedures; applies advanced technical… more
- Novo Nordisk (Clayton, NC)
- …Oversee area content and provide process knowledge, periodic reviews, validation processes, and reporting + Demonstrate technical knowledge of assigned processes ... Serve as process subject matter expert (SME) for assigned CMO production/process area . Support people, equipment and processes for our operations areas to meet… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The QA Specialist , Operations (Nights) is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes for ... time event triage and implementation of immediate response to identified deviations c. Area changeover and return to service d. Real time WO oversight per applicable… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the ... needs in a very timely and accurate manner. **_Sr Reg Affairs Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative… more
- IQVIA (Durham, NC)
- …guidance in this area to less experienced CEVA staff. + Apply specialist expertise within the CEVA department. + Collaborate with other CEVA managers to resolve ... delivery excellence of projects as assigned by CEVA (Clinical Event Validation and Adjudication) management, covering single or multiple CEVA functions. Provide… more
- Noblis (Raleigh, NC)
- …and Waste Reduction Noblis provides technical and programmatic support in the broad area of weapons systems and platforms to execute the mission of these DoD ... Programs. We seek to identify personnel with knowledge and experience in this area to join our team of talented professionals to successfully support the strategic… more
- Fujifilm (Holly Springs, NC)
- …QC RM area * Provides risk assessments, regulatory standards/guidance, and validation documents, as required to support QC business and compliance * Participates ... **Position Overview** The Sr. Specialist 2, Global QC Raw Materials GMP Support is responsible for supporting, leading, and participating in activities within the… more
- Lilly (Durham, NC)
- …and QA oversight to GMP operations in the Device Assembly and Packaging (DAP) area . The QA Floor Support Specialist supports multiple production functions (from ... the world. **Position Description:** The Quality Assurance Floor Support Specialist works as a member of the QA Floor...experience in GMP production environments. + Previous facility or area start up experience. + Knowledge of Validation… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …may coordinate the installation, maintenance, calibration and repair work in their area of responsibility or provide oversight of a location's utility systems. ... manages team(s) of technicians, contractors and other staff, perform regular area inspections, maintain and troubleshoot equipment, and assign work to employees.… more