- Fujifilm (Holly Springs, NC)
- …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 Conditions & Physical Requirements:** + Ability to discern… more
- ThermoFisher Scientific (High Point, NC)
- …Follow quality standards in accordance with company policy and cGMP and FDA requirements. Understanding of cGxP requirements. + Troubleshoot & support manufacturing ... learn PLC formats with heavy emphasis on Allen-Bradley PLC/HMI hardware and software : SLC, PLC, ControlLogix, and PanelView. + Strong understanding of electrical… more
- Transylvania Vocational Services (Brevard, NC)
- …including food safety, sanitation, and continuous improvement. + Ensure compliance with USDA, FDA , OSHA, SQF, OU, and other regulatory bodies. + Act as liaison with ... Silliker, etc.) + Proficient in the use of laboratory equipment and quality-related software + Knowledge of food packaging and blending processes a plus + Background… more
- Teleflex (Morrisville, NC)
- …* Basic understanding of industry regulations such as ISO 13485, ISO 14971, and FDA 21CFR820. * Proficient in MS Office and Minitab or other statistical software ... . * Strong organizational and time management skills to meet deadlines while managing multiple projects. * Strong analytical and critical thinking skills. * Proficient in technical report writing and review. * Strong verbal and written communication skills. *… more
- Fujifilm (Raleigh, NC)
- …+ Provide on-going customer support for HCUS MRI products, including: + Software updates. + System upgrades. + Performance troubleshooting follow-up visits. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- ThermoFisher Scientific (Wilmington, NC)
- …and time management proficiencies + Solid knowledge of PPD SOPs, GxPs, and FDA /ICH guidelines + Thorough understanding of sponsor/CRO business practices and an in ... of 15-20 lbs. + Ability to access and use a variety of computer software developed both in-house and off-the-shelf + Ability to communicate complex information and… more
- Lilly (Durham, NC)
- …manufacturing lines. + Maintain the MES system architecture (platform, software , interfaces, and client virtualization tools) by coordinating lifecycle management, ... Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) and other applicable regulations (eg privacy, OSHA,… more
- Fujifilm (Holly Springs, NC)
- …in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. * High level of familiarity/understanding of validation of ... knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software * Understanding of cell culture, upstream processes, large scale… more
- Lilly (Concord, NC)
- …or equivalent + Prior supervisory experience + Basic computer skills (desktop software , MS Office) are required. + Previous experience in operations or directly ... in manufacturing/operations with 2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + STEM degree or certification +… more
- Fujifilm (Durham, NC)
- …actions. + Proficiency in validation documentation and regulatory standards (eg, FDA , EMA). + Familiarity with continuous improvement methodologies and tools. + ... managing project teams and stakeholder relationships. + Proficiency in project controls software and integration with corporate systems. + Ability to analyze complex… more