- Fujifilm (Research Triangle Park, NC)
- …related to enterprise-level IT/OT systems. Compile technology related documentation for GxP and critical IT technologies. Participate in system validation and ... testing processes as required. Approve validation documentation together with relevant ITQ. Represent IT system in connection with audits and inspections. (35%) + Consult with system administrators, vendors, and other department personnel to provide guidance… more
- ThermoFisher Scientific (Holly Springs, NC)
- …School Diploma/GED Associates/Bachelors preferred Experience: Experience in laboratory and in GXP environments. Utilization of GDP in all record keeping. 2+ years ... of progressive proven experience preferred. 3+ years in customer service environment. **Knowledge, Skills, Abilities:** Proven verbal, written and presentation skills. Must maintain Thermo Fisher Scientifics' Four-I Values. Shown excellence in customer… more
- GRAIL (Raleigh, NC)
- …and quality to help keep these systems operational while adhering to GxP / GLP/GMP regulations and quality standards when applicable. Strict adherence to Standard ... Operating Procedures, Work Instructions, and Quality Standards in a FDA-regulated facility are mandatory. In addition, this individual will also be involved in the installation and start-up of new equipment and assist with any commissioning and qualification… more
- CACI International (Fort Bragg, NC)
- …requirements. The supported technologies include ArcGIS, ArcGIS Server, SOCET GXP , OpenGeo Software Suite, Microsoft Windows Server, Microsoft Active Directory, ... NetApp Storage Solutions, VMWare, and Linux server software. The candidate's experience and knowledge will be vital to system architecture backup and recovery plans, the implementation of security 4.5.2 protocols and patches, the monitoring of system health… more
- Catalent Pharma Solutions (Morrisville, NC)
- …6+ years related experience required. + Experience in testing in a GMP/ GXP environment. Includes an understanding of good documentation skills, data integrity, and ... compliance. + Familiar with compendial testing including USP, EP, and JP compendia. + Able to organize workload and complete all required assignments in a timely manner. + Ability to interpret scientific data and form conclusions as needed and perform… more
- Reckitt (Wilson, NC)
- …for manufacturing / utility operations. + Serve as automation SME and ensure compliance with GxP , FDA, EU Annex 11, and 21 CFR Part 11 requirements. + Validate and ... maintain automated systems; integrate MES, historians, robotics, and sensor technologies. + Manage capital projects involving automation and electrical systems; oversee commissioning and vendor collaboration. + Coordinate cross-functional teams to implement… more
- Cognizant (Raleigh, NC)
- …business systems analyst with a deep understanding of business processes under GxP , ISO, and regulatory compliance Knowledge of Mfg. Process Controls and Reporting ... program Awareness of Electronic Lot History Records using Camstar Software for Medical Device/ Pharma industries Implement and execute the shopfloor transaction using OpCenter Execution Discrete in Discrete manufacturing Industry Experienced in Camstar (V8.x)… more
- Cambrex High Point (High Point, NC)
- …of at least 3 years of relevant background/leadership in GXP /QA/regulatory compliant pharmaceutical laboratory environment or Quality Assurance/Regulatory Affairs ... role (prefer late phase/commercial experience). Knowledge of GMP manufacturing and analytical techniques to support QA and Regulatory process. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Sedentary work,… more
- Novo Nordisk (Durham, NC)
- …to collaborate in a team environment required + Pharmaceutical industry experience ( GxP ) preferred + Data Visualization with Tableau experience required + Experience ... in applying systematic and rigorous analytics methods to improve data-related business processes required + Strong IT Knowledge, demonstrating ability to handle most situations independently and with minimal guidance required + Ability to identify better… more
- Kuehne+Nagel (Hillsborough, NC)
- …+ Keep up to date with KN global and country specific GXP standards and requirements. + Implement/maintain safety, security, quality, housekeeping and sanitation ... programs, as applicable. + Work closely with other departments to deliver high level of service to healthcare customers. + Perform other detailed (job specific) duties as assigned. **What we would like you to bring** + In depth knowledge of operational… more