- Insight Global (Raleigh, NC)
- …Raleigh, NC, locations. This lead is highly skilled in Computer Systems Validation (CSV) with strong GxP experience and responsible for the development, maintenance, ... IT teams, Quality, and Regulatory functions to define computer system validation requirements and ensure IT project delivery, application management and change… more
- Revlon (Oxford, NC)
- …Assesses the impact of deviations, CAPAs, and associated change request on the validation status of equipment and/or systems. + Assess changes via NPD, change ... processes. + Prepare detailed plans for coordination and execution of validation activities with various stakeholders (Operations, R&D, QC, etc.) and follow… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …cross-functional challenges. + Establish and implement standards, ensuring adherence to FDA regulations and GxP. **Key Responsibilities (for all levels):** + Plan, ... expert, providing support for systems like DCS, PLC, SCADA, BAS, and validation processes. + Foster a collaborative and cooperative work environment while ensuring… more
- Fujifilm (Holly Springs, NC)
- …from project phase through operational readiness, and provides oversight of validation program execution for these processes. This role collaborates with other ... and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports. *… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …deep expertise in SAP MM & Segmentation, regulatory compliance (such as GxP and FDA ), and life sciences processes. As a Business Systems Analyst, you will play a ... SAP solutions comply with relevant regulatory requirements, including GMP, FDA 21 CFR Part 11, and other applicable standards....Part 11, and other applicable standards. + Partner with Validation teams to develop and maintain validation … more
- Perdue Farms, Inc. (Lewiston Woodville, NC)
- …interface with internal, external, customer and regulatory (USDA and/or FDA where applicable) inspectors regarding sanitation related non-conformance reports and ... + Sanitation Standard Operating Procedures (SSOP) + Monitoring Verification and Validation of the Cleaning Process (ATP, Indicators, Pathogens, Allergens, Adjacent… more
- Fujifilm (Holly Springs, NC)
- …and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports * ... Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems * Generates, reviews, and approves QA… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …working a 2-2-3 rotation schedule. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry ... with LIMS data entry to support LIMS maintenance and validation activities. + Assists with revisions to QC department...Experience participating in the management of regulatory audits (ie FDA , MDSAP, ISO, OSHA, EPA, etc.). + Experience in… more
- Cambrex High Point (Durham, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss ... safe laboratory work practices. Interacts with clients and participates in FDA and/or client audits. Maintains professional knowledge through familiarity with… more
- Cambrex High Point (Durham, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Provides leadership and mentoring across the analytical team ... safe laboratory work practices. Interacts with clients and participates in FDA and/or client audits. Maintains professional knowledge through familiarity with… more