- Fujifilm (Holly Springs, NC)
- …risk assessments, protocols and reports + Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs) + As technical SME, ... leads generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies + Generates and executes process training and consults on topics related to manufacturing and process + Leads and… more
- Fujifilm (Holly Springs, NC)
- …validation reports (PVRs) and investigations * Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs) * As technical SME, ... supports generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies * Generates and executes process training and consults on topics related to manufacturing and process * Leads… more
- Fujifilm (Holly Springs, NC)
- …in large pharma/biotech operations orproject * Experience with electronic batch records, root cause analysis,technical writing, and initiation of investigations ... **Preferred Requirements** * Experience working in facility start-up environment * Experience working in a pharmaceutical manufacturing environment * Lean Six Sigma or similar certification **WORKING CONDITIONS & PHYSICAL REQUIREMENTS** + Will work in… more
- Fujifilm (Research Triangle Park, NC)
- …microbiological testing of clean utility, environmental monitoring, and manufacturing batch samples. This role performs routine laboratory testing and support ... activities and participates in continuous improvement initiatives. **Company Overview** At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's most… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews ... as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality manager at business unit meetings, and project meetings.… more
- Amgen (Holly Springs, NC)
- …contributions within Process Development Attribute Sciences at Amgen's FleX Batch facility. This laboratory-based role will evaluate attributes of materials ... based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting. + Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing. +… more
- ASM Research, An Accenture Federal Services Company (Raleigh, NC)
- …resolving processing issues, managing COD processing status, analyzing data and outreach for batch processing issues and more. Ensures staff has the utmost focus on ... customer satisfaction and adherence to established Service Level Agreements (SLAs). + Supervises and monitors day-to-day activities of Customer Service Support Services to ensure all matters adhere to the established Service Level Agreements (SLAs). + Develops… more
- Cognizant (Raleigh, NC)
- …are seeking an experienced MES Werum PAS-X Specialist to support Electronic Batch Record (EBR) implementation for a leading pharmaceutical client. The role involves ... system administration, configuration, and integration of Werum PAS-X with SAP and other Level 2 systems, ensuring compliance with GxP and validated environments. Key Responsibilities: + Gather business requirements and perform analysis for MES EBR… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and proper gowning + Follow Standard Operating Procedures (SOP's) and complete Batch Production Records (BPR's) + Complete record keeping in accordance with current ... Good Manufacturing Practices + Operate manufacturing process control system and equipment + Operate Clean In Place (CIP) equipment + Perform in process analytical analysis + Monitor status of manufacturing processes + Assist in sampling operations + Assist in… more
- ThermoFisher Scientific (Greenville, NC)
- …with area SOPs and current cGMP. + Verify and document production activities in batch records, logbooks, and controlled forms. + Operate vial tray loaders. + Filter ... integrity testing. + Clean pre and post use change parts and prep for sterilization. + Maintain/clean classified and non-classified areas. This includes but is not limited to the aseptic core. + Record and complete accurate documentation according to GMP… more