- Fujifilm (Holly Springs, NC)
- …subject matter expert (SME) for their process respective area(s) * Coordinates Batch Planning including process template creation and import and management of ... training, onboarding, and curriculum development and management * Coordinates non- batch activities and creation of associated documentation for changeover, PMs,… more
- Stahlbush Island Farms (Corvallis, OR)
- …support the Quality Department through additional oversight of lab personnel, batch paperwork review and data entry, cross-training, and coordinating and assisting ... Incident Response and ON HOLD programs to document investigations. + Verify batch paperwork daily, and report quality concerns to appropriate personnel. Responsible… more
- ThermoFisher Scientific (Greenville, NC)
- …operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development ... deviation investigations of moderate to high complexity + Performs quality batch record review + Aids in identification of continuous improvement opportunities;… more
- Hawaiian Electric (Honolulu, HI)
- …troubleshoot, and implement programs, stored procedures, forms, reports, interfaces, workflows, batch jobs, etc. in one or more of the following languages/systems: ... troubleshoot, and implement programs, stored procedures, forms, reports, interfaces, workflows, batch jobs, etc. in one or more of the following languages/systems:… more
- Johns Hopkins University (St. Petersburg, FL)
- …graduate research. + Authoring, version control, and training on SOPs, batch records, and deviation/CAPA documentation for cell-therapy process development. + ... Experience using electronic batch records (eBR), QMS and/or LIMS for chain-of-identity/chain-of-custody and data integrity. + Experience with cell-therapy QC assays:… more
- Kerry (Norwich, NY)
- …Operator is responsible for operating and helping with all blenders, packaging, batch setting, filtration devices, TRS, HTST's, cooler, evaporators, dryer, and CIP ... approved methods to ensure finished product meets targeted specifications. + Fill out master batch records on time and in a neat, orderly fashion according to GMP's.… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …standards and established quality requirements + Prepare and review manufacturing batch record and other engineering qualification documents as required + ... Controls and Planned Deviations when required + Reviews manufacturing/ Packaging batch records and Engineering qualification documents + Performs other functions as… more
- Merck (Rahway, NJ)
- …system. Knowledge of PAS-X is preferable. + GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance with industry ... Manufacturing Practices (GMP), Laboratory Techniques, Manufacturing Quality Control, Master Batch Records, Material Selection, Pharmaceutical Process Development, Production Planning,… 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
- ThermoFisher Scientific (St. Louis, MO)
- …QA on-the-floor activities that include but are not limited to in-process batch record review, logbook review, GEMBAs of all manufacturing areas, providing feedback ... from a quality perspective and provide QA-related input + Perform manufacturing batch record and documentation review with excellent attention to details for… more