- Lilly (Indianapolis, IN)
- …+ Collaborate with the global MES team to align on data models, batch execution logic, and system interfaces between PharmaSuite and adjacent systems including ERP ... PharmaSuite including architecture, configuration, and deployment. + Experience with batch management, EBR design, material traceability, and exception management. +… more
- Lilly (Indianapolis, IN)
- …+ Implement and refine processes to handle short lead-time orders, small batch sizes, and unique clinical material requirements. + Drive ERP/MRP enhancements to ... plans. + Work closely with Clinical Supply Operations to ensure alignment on batch planning and shipment timelines. _Risk & Compliance Management_ + Identify and… more
- Astrix Technology (New Brunswick, NJ)
- …include operating large-scale equipment (500L-2000L), maintaining accurate and complete batch records, and ensuring strict adherence to quality and safety ... equipment ranging from 500L to 2000L. + Maintain detailed and accurate batch records in compliance with GMP requirements. + Perform routine cleaning, maintenance,… more
- Herbalife (Lake Forest, CA)
- …activities and collaborating with cross functional group to ensure manufacturing batch records encompass all compliance and process requirements. **HOW YOU WOULD ... a timely basis. + Supports documentation activities (ie creation of manufacturing batch records) for sister plants: monitor production schedules and follows-up to… more
- Abbott (Casa Grande, AZ)
- …required. + **Experience:** + 3+ years in QA-related roles (eg, Lab Analyst, Batch Log Auditor). + 2+ years as a Document Coordinator preferred. + **Skills ... & Knowledge:** + Familiarity with manufacturing processes and batch preparation. + Knowledge of regulatory standards for infant formula and nutritional products. +… more
- Astrix Technology (OH)
- …with difficult scale up situations. + Provide supporting documentations ( batch records, specifications, hazard sheets, safety review packages, air emissions, ... of processing, participate on the floor as appropriate and review executed batch records. + Interact closely with our chemistry and quality departments throughout… more
- Lilly (Indianapolis, IN)
- …You will combine technical leadership with strategic execution-driving DS batch technology transfer and delivery, ensuring robust clinical manufacturing performance, ... Quality System compliant manufacturing master production records and review of executed batch records where applicable + Ensure robust execution of DS batches with… more
- Astrix Technology (Lake County, OH)
- …scale-up scenarios. + Prepare and maintain key documentation including batch records, specifications, hazard assessments, safety review packages, emissions data, ... ongoing production, assist on the manufacturing floor as needed, and review completed batch records. + Work closely with chemistry and quality teams throughout the… more
- PCI Pharma Services (San Diego, CA)
- …customer complaints + Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch ... Records for cGMP compliance and clarity + Process integration and procedural harmonization with other PCI sites + Customer and Regulatory Audits, including coordination and submission of PCI's responses + Communication and escalation of quality issues to Site… more
- Lilly (Indianapolis, IN)
- …aspects of external API manufacturing sites, including but not limited to batch record review, disposition, deviation management, and change control. + Conduct ... + Review and approve quality-related documents, such as manufacturing master batch records, validation protocols and reports, stability data, and analytical methods.… more
Recent Jobs
-
IT Vendor Management Lead (SaaS Platforms)
- Humana (Lansing, MI)
-
Ski Area Associate - Base Operations (25-26 Season S00601)
- Middlebury College (Hancock, VT)
-
Sr Program Manager, AI
- Vivint (UT)
-
Pharmacy Pre-Grad Intern - WM
- Walmart (Post Falls, ID)