- 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
- Novo Nordisk (Clayton, NC)
- …make what matters. The Position Responsible for the production activities & validation . Ensures relevant compliance issues are addressed & handled in close ... current NN procedures & requirements from health authorities are reflected in the validation planning & quality related decisions + Support validation projects… 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
- Norstella (Raleigh, NC)
- Data Enhancement Specialist Company: MMIT Location: Remote, United States Date Posted: Apr 22, 2025 Employment Type: Full Time Job ID: R-1137 **Description** **_Why ... the entire drug development journey. **The Role:** As a Specialist on the Enterprise Access & Data Expertise Team...understanding of knowledge, data, and product to resolve data validation requests in accordance with MMIT standards and client… 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
- 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