- Fujifilm (Holly Springs, NC)
- …Delivery + Establishes and facilitates QA readiness processes and plans for site cGMP go live across the business functions and site buildings + Establishes KPI, ... and/or familiarity with Quality Risk Management principles + Validation, cGMP manufacturing operations and/or Quality oversight **Physical and Work Environment… more
- Stryker (Durham, NC)
- …and repairing mechanical issues + Documenting maintenance activities in compliance with cGMP . + Assist with the design, development, and improvement of production ... hands-on problem-solving skills + Familiarity with FDA regulations, ISO 13485, and cGMP + Experience with maintenance/quality systems a plus + Lean Manufacturing or… more
- Fujifilm (Holly Springs, NC)
- …for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility * Ensures project and operational quality objectives are ... experience working in a GMP regulated environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.… more
- Fujifilm (Holly Springs, NC)
- …**OR** + Equivalent Military training/experience **Preferred Requirements** + Previous cGMP manufacturing operations experience + Understanding of change management, ... investigations, CAPAs and CIs + BioWorks or BTEC Capstone cGMP coursework preferred **WORKING CONDITIONS & PHYSICAL REQUIREMENTS** + Ability to discern audible cues… more
- ThermoFisher Scientific (Greenville, NC)
- …within a Science and/or Engineering field preferred. + 5+ years in a cGMP quality/manufacturing role in a pharmaceutical, food or cosmetic environment with 1+ years ... in management of a team in a regulatory environment + Experience in cGMP principles pertaining toinvestigations and CAPA + Expertise in technical writing skills +… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …overseeing complex microbiological testing and environmental monitoring (EM) in compliance with cGMP , USP, FDA, and internal quality standards. This position is in a ... + Review lab test data and their integrity and adherence to SOPs and cGMP . Compliance: + Maintain current knowledge of regulatory and industry standards, trends and… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …hydraulic, pneumatic controls, valves, pumps, motors, steam components, AB PLC, cGMP and CMMS. Ability to read ladder logic, troubleshoot PLC's, electrical ... in the operation of high speed, highly automated, production equipment (in a cGMP environment within the last 6 years desired). 3. Basic Computer Skills required;… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …of compliance, safety, and conformance to procedures as specified by SOP's, cGMP 's, and Osha standards. **Education** Position requires a Bachelor's degree in one ... related to raw plasma, inventory controls, and strong knowledge of cGMP 's and other regulatory requirements. Must demonstrate leadership and independent decision… more
- ThermoFisher Scientific (Greenville, NC)
- …of DPI's pharmaceutical license to operate from a Current Good Manufacturing Practices ( cGMP ) compliance standpoint and to ensure no harm is done to patients due ... to ensure continuous improvements regarding the most recent national and international cGMP compliance standards and to accomplish compliance in the most efficient… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and repairing mechanical and electrical systems. + Experience working in a cGMP /Regulated environment desired. + Able to read ladder logic and troubleshoot/repair ... of existing procedures/processes. + Adheres to documentation requirements in a cGMP compliant manner in accordance with applicable Quality Policies. + Follows… more