- Lilly (Concord, NC)
- …expertise in PharmaSuite OR Syncade supporting, developing and validating global electronic batch records to fulfil business needs. Working closely with global and ... 21 CFR Part 11, Annex 11). + Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. + Strong documentation skills and attention… 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
- 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
- Actalent (Winston Salem, NC)
- …and maintaining quality standards. + Revise, update, and ensure adherence to SOPs, batch records, and MS forms to maintain GMP compliance. + Lead routine cycle ... and production tracking. + Ensure accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices. +… 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
- Pfizer (Sanford, NC)
- …and/or UF/DF skids with varying levels of automation. + Follow SOPs and batch records for unit operations + Supports operation of manufacturing equipment and issue ... and/or UF/DF skids with varying levels of automation. + Follow SOPs and batch records for unit operations + Supports operation of manufacturing equipment and issue… 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
- 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
- Mallinckrodt Pharmaceuticals (Raleigh, NC)
- …panel boards, indicators, PLC displays, and DCS screens following applicable batch records, procedures and good documentation practices + Packages, weighs, samples, ... procedures and good manufacturing practices + Maintains detailed operating reports and batch records, including notes on problems and records on added weights,… more
- Reynolds American (Winston Salem, NC)
- …for the electronic tracking systems (MES, . Ignition). Complete and sign each batch report. . Physically place and visually inspect to ensure that the correct ... batches. . Communicate with other employees and supervision to ensure correct batch is being processed and equipment is operating appropriately. . Notify Supervision… more