- ThermoFisher Scientific (Greenville, NC)
- …Analysis to support deviation investigations of moderate to high complexity + Performs quality batch record review + Aids in identification of continuous ... operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development… more
- Mallinckrodt Pharmaceuticals (Raleigh, NC)
- …reviews, and updates documentation for managing the process, including operating reports, batch records , P&IDs, etc. Reviews operating reports and batch ... operations + Must be able to climb stairs and ladders for equipment installation review , monitoring and troubleshooting + Must be willing and able to wear PPE… more
- Pfizer (Sanford, NC)
- …Deliver and maintain detailed process schedules aligning the High-Level Schedule (Plan of Record ) and Standard Work models to ensure the manufacture of product is ... ensure a high level of demand accuracy. + Facilitate batch tracker to ensure the batch is...plan (schedule attainment) and actual production vs Plan of Record + Implement new scheduling systems and create real-time… more
- ThermoFisher Scientific (Greenville, NC)
- …QA representative in root cause analysis to support deviation investigations. + Perform batch record review . **Qualifications:** + Associate's degree in ... with respect to manufacturing, filling, packaging and inspection, and associated non batch specific activities in the Sterile facility for both commercial and… more
- Amgen (Holly Springs, NC)
- …and key stakeholders. + Ensure work order documentation is completed accurately. + Review maintenance reports, forms, plans and records . + Identify waste, ... drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies...to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class… more
- Reckitt (Wilson, NC)
- …and customer orientation + Proficient in ERP (SAP preferred), production systems, batch records , deviation and quality systems management + Advanced knowledge ... full compliance with cGMP, FDA, and internal quality standards, overseeing batch documentation, deviation management, and audit readiness. + Drive "Right First… more
- ThermoFisher Scientific (Greenville, NC)
- …scale-up and commercialization, supporting the development of mitigation strategies. + Draft and review batch records , protocols, and reports to support ... manufacturing processes for oral solid dosage (OSD) products in both traditional batch and continuous manufacturing environments. You will contribute to scaling up… more
- Amgen (Holly Springs, NC)
- …and key stakeholders. + Ensure work order documentation is completed accurately. + Review maintenance reports, forms, plans and records . + Identify waste, ... drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies...to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …established deadlines, company and regulatory requirements. + Coordinates the reviews of relevant records , (eg batch records , quality control data, quality ... for internal audit and external audit (vendor/CTL) + Keep records maintained for audit reports pertains to vendors and...view data such as: shelf life and Quality Info Record (QIR) based on Vendors qualification status. + Support… more
- Broadcom (Durham, NC)
- …are identified with Broadcom Software - When appropriate, request documentation for review and analysis to determine the problem and provide applicable maintenance ... to resolve the problem(s) if available - Efficiently utilize available resources to review and analyze the documentation when it is sent by the customer - Upload the… more