- Amgen (Holly Springs, NC)
- …that reporting functionality is incorporated for all unit operations for production Batch records , cleaning, and sterilization systems, including Audit trail and ... version control. + Responsible for ensuring that service contracts with all OEMs for systems are established for service and support needs, including service banked hours for specialized support needs. + Ensure that all automation staff are adequately trained… more
- Fujifilm (Holly Springs, NC)
- …process area + Recommend and perform documentation updates + Coordinate non‐ batch activities and creation of associated documentation for tech transfer, changeover, ... maintenance plans (PMs), column packing + Create change management records , investigations, corrective and preventive actions (CAPAs) and continuous improvement… more
- Black & Veatch (Cary, NC)
- …systems. + Streaming APIs (eg, Kafka, WebSockets) for real-time data integration. + Batch and ETL/ELT APIs for large-scale data processing. + Webhook APIs for ... of the following: criminal/civil background check, drug screen, and motor vehicle records search, in compliance with any applicable laws and regulations. **Work… more
- UNC Health Care (Goldsboro, NC)
- …as a resource and role model for teammates. 2. Produces small to large batch goods using advanced and a full range of classical and contemporary cooking, plating ... products, reads menus, estimates food requirements, check production, and keep records in order to accurately plan production requirements and requisition supplies… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …technical oversight of downstream manufacturing operations at CDMOs, including review of batch records , deviation investigations, and change controls. + Lead or ... significantly contribute to troubleshooting efforts and root cause investigations for downstream process deviations or performance issues at CDMOs. + Analyze downstream process data (via CPV program, campaign summaries) to monitor performance, identify trends,… more
- Lilly (Durham, NC)
- …Veeva Suite. + Create and manage quality master data in SAP including q-info records and inspection plans for materials. + Protect the integrity and accuracy of data ... experience. + Knowledge of operations business processes such as batch disposition, materials management, laboratory specification/method management. + Previous… more
- Reckitt (Wilson, NC)
- …FDA, and Reckitt quality standards. Maintain accurate and complete documentation ( batch records , SOPs, deviation reports). + Cross-Functional Collaboration: Work ... closely with Quality, R&D, Operations, and Supply Chain teams to ensure seamless operations and product launches. + Equipment & Technology: Evaluate and recommend new equipment or technologies to enhance liquid and OSD processing capabilities. **_This role is… more
- Fujifilm (Holly Springs, NC)
- …stakeholders *Utilizes new knowledge to promptly drive data-based decisions *Ensures master batch records (MBRs) and sample plans support PA requirements ... *Negotiates with cross-functional stakeholders *Oversees data stewardship and data governance activities, including alignment with global FDB network *Ensures data and analyses are findable, accessible, interoperable, and reusable to internal and external… more
- ThermoFisher Scientific (Greenville, NC)
- …production and process optimization + Author and review technical documents such as batch records , protocols, and reports + Participate in client discussions and ... internal meetings as technical support **Education** Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific field is required. Master's degree preferred. **Experience** + Minimum of **2 years of relevant industry… more
- Catalent Pharma Solutions (Greenville, NC)
- …machinery and equipment and recommend corrective or preventative measures. + Ensure all batch records and logbook entries are accurately documented and compliant ... with SOPs and FDA cGMP guidelines. + With minimal supervision, conduct setup, changeover, and manufacturing activities with adherence to SOPs and safety requirements. + Other duties as assigned. **The Candidate** + High school diploma or equivalent with at… more