- Lilly (Concord, NC)
- …Diploma or GED + Prior supervisory experience + Basic computer skills (desktop software , MS Office) are required. + Previous experience in operations or directly ... manufacturing/operations with 2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + STEM degree or certification… more
- Fujifilm (Holly Springs, NC)
- …Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility **Preferred Requirements** * 2+ years of experience in ... knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software **Working & Physical Conditions** Ability to discern audible cues.… more
- Sumitomo Pharma (Raleigh, NC)
- …Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency ... in BASE SAS and R, or other statistical software is advantageous + Effective verbal and writing skills **Education and Experience** + PhD or MS in statistics or… more
- Honeywell (Charlotte, NC)
- …recipe management, quality management systems, regulatory compliance (GMP, FDA , EMA), manufacturing analytics, digital transformation initiatives, process ... Solutions, and Industrial Automation business segments - powered by our Honeywell Forge software - that help make the world smarter, safer and more sustainable.… more
- ITG Brands (NC)
- …regulations + Ensure projects adherence to regulatory compliances, including Group & FDA . + Awareness of evolving legislation relevant to machinery installations & ... maintenance programs. + Business acumen. + AUTOCAD and/or similar drawing software . **Work Environment and Physical Demand** + Requires moderate physical effort.… more
- Sumitomo Pharma (Raleigh, NC)
- …risk assessment, and safety data analysis + Proficiency with safety databases and software + Ability to evaluate and write case reports and prepare regulatory ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- Kelly Services (Winston Salem, NC)
- …FMEA, Quality by Design (QbD), Design of Experiments (DoE), and statistical software (eg, JMP). + Comprehensive understanding of regulatory requirements from FDA ... , EMA, and ICH guidelines relevant to biologics and cell therapies, with experience preparing IND and BLA submissions. + Familiarity with analytical techniques including flow cytometry, ELISA, and potency assays supporting process development and product… more
- Fujifilm (Holly Springs, NC)
- …plumbing, chemical treatment, and control systems + Familiarity with GMP, FDA , and other regulatory requirements + Effective communication, both written and ... Computerized Maintenance Management System (CMMS) or other data tracking software experience + Experience developing and implementing preventative maintenance… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …utilize SOP and documentation to record data manually or through identified software applications. + Operate high speed manufacturing equipment, in some cases highly ... OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + Ability… more
- Fujifilm (Holly Springs, NC)
- …role, required + 3+ years of experience in GMP operations in an FDA regulated facility **Preferred Requirements:** + Experience and working knowledge of ASTM E2500, ... Smartsheet, Trackwise, Veeva, SAP, and/or Kneatvalidation software + Previous biopharmaceuticals experience: + Cell culture, upstream processes, large scale recovery… more