- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting all ... systems noted above. + Improves supplier quality performance for batch record review and release process for OAPI GMP...activities. + Seven years of product quality experience performing batch review and release activities of suppliers or contract… more
- BD (Becton, Dickinson and Company) (Mebane, NC)
- …Skill Matrix file. + Support internal/external audits related to training. + ** Batch Record Review:** Performtimelyandaccuratereview of batch records to ensure ... Support updates to manufacturing documentation including SOPs, work instructions, and batch records. + **Standard Work Documentation:** Assistin the creation and… more
- Amgen (Holly Springs, NC)
- …most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional ... stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Batches. OVERALL JOB RESPONSIBILITIES Responsibilities Results Expected/ Target Prepare protocols/ Batch Records for scale-up, Engineering Batches for the new ... process control for all products Documentation: 1.Should be capable of drafting Batch Records and Protocols/Reports for new products. 2. Should understand and… more
- Herbalife (Winston Salem, NC)
- …the packaging of manufactured products which include following packaging electronic batch records and standard operating procedures. In addition, this position will ... other related packaging activities. DETAILED RESPONSIBILITIES/DUTIES: + Follow electronic batch record, enter oracle transactions and properly and timely document… more
- Lilly (Concord, NC)
- …meet production schedule. + Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) + Drives key departmental objectives including ... + Previous experience with Manufacturing Execution Systems and electronic batch release. + Knowledge of lean manufacturing principles Additional Information:… more
- Ensono (Raleigh, NC)
- …A Senior Data Center Operations Analyst is responsible for system monitoring, production batch monitoring, workload throughput as well as batch and system task ... abend recovery for internal and external client MVS / ZOS / VM/VSE environments. + Primary Tools : TWS OPC, BMC Ops AMI, zCAM, Mainview, Control-D, Mainframe Console & HMC (Must) + Ticketing Tools : Service Now / ATLAS + **Work from Client location at Raleigh… more
- Ralliant (Raleigh, NC)
- …and "data contracts" via **OIC** : what moves, when (real-time vs batch ), validation rules, failure handling, retries, reconciliation, and business-impact SLAs + ... → adoption) + Solid understanding of integration concepts (APIs/iPaaS/ETL; real-time vs batch tradeoffs) and how data quality impacts customer experience + Strong… more
- ThermoFisher Scientific (Greenville, NC)
- …of GMP manufacturing operations, including aseptic processing + Perform and lead batch record review to ensure accuracy and compliance with regulatory and internal ... regulations, FDA guidance, and pharmaceutical quality systems + Strong expertise in batch record review, deviation management, CAPA, and root cause analysis +… more
- CVS Health (Raleigh, NC)
- …Streams & Tasks, and job orchestration to enable near-real-time and batch analytical workloads. + Implement data modeling and governance patterns within ... Streams & Tasks, and job orchestration to enable near-real-time and batch analytical workloads. + Implement data modeling and governance patterns within… more
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