- 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)
- …& finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. ... 50,000 employees. FFEx is a newly established and growing area with the responsibility to design, plan, and build...of raw materials. Quality oversight, review & approval of validation activities associated with minor 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
- Norstella (Raleigh, NC)
- Data Enhancement Specialist Company: MMIT Location: Remote, United States Date Posted: May 23, 2025 Employment Type: Full Time Job ID: R-1161 **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
- 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
- Veterans Affairs, Veterans Health Administration (Asheville, NC)
- Summary Education & Learning Resources has one opening for a Nursing Education Specialist . The Education Specialist functions across the Western North Carolina ... educator, consultant, facilitator, change agent, leader and researcher. The Education Specialist is critical to supporting the development of frontline staff,… 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
- BD (Becton, Dickinson and Company) (Charlotte, NC)
- …placement experience** **required** **.** As directed by the Clinical Manager, the Clinical Specialist role will be focused on, but not exclusively limited to, the ... conversion management process is clinically effective throughout the timeline of pre- validation to retention. + Establishes excellent rapport with TMs across both… more
- Caterpillar, Inc. (Sanford, NC)
- **Career Area :** Engineering **Job Description:** **Your Work Shapes the World at Caterpillar Inc.** When you join Caterpillar, you're joining a global team who ... (BCP) Division at Caterpillar is seeking a **Technical Regulatory Compliance Engineering Specialist ** to join the Regulations and Product Compliance team. This role… 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
- TD Bank (Charlotte, NC)
- …Remediation Quality Assurance Review & Challenge Coordination Senior Business Management Specialist will have appropriate Audit or Risk and Controls subject matter ... concern level, ensuring effective remediation, leading to successful Internal Audit validation . This role engages with stakeholders to provide ongoing support as… more
- Lilly (Concord, NC)
- …make life better for people around the world. **Organization Overview:** The Warehouse Specialist will join the WH operations team and support system level detailed ... storage equipment commissioning (ASRS/AGV) and qualification activities, commercial product validation and ultimately be responsible for the physical handling of… 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
- TD Bank (Charlotte, NC)
- …Control Remediation Quality Assurance Practice/Methodology & Testing Business Management Specialist offers support in maintaining methodology supporting the end to ... findings and increase the likelihood of passing Internal Audits and Regulator validation . Schedule: Monday - Friday, standard business hours **Depth & Scope:** +… 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