- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices. In addition, personnel in this position ... specific batch records. - Maintain documentation and functional work areas to GMP standards. - Communicates effectively to area leadership and all cross functional… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Critical Investigations to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct. + ... Quality Control departments. + Represent Glenmark as appropriate in FDA , notified body, internal and other regulatory audits. +...the QC team, good communications skills, front runner, and GMP trainer. + Will be an added advantage if… more
- Papa John's International (Garner, NC)
- …at proper cooling temperature(s). + Maintain and document Good Manufacturing Practice ( GMP ) standards on cleanliness and sanitation to insure product is free of ... Sanitation and HACCP policies & procedures, federal, state and local regulations (OSHA, FDA , DOL) and all Papa John's International, Inc., policies & procedures. +… more
- Actalent (Cary, NC)
- …Biotech, Laboratory, or Food & Beverage industries. + Advanced knowledge of GMP manufacturing environments. + Proficiency in Revit, AutoCAD, and Microsoft Office ... or experience. + Experience with industry standards such as ASHRAE, SMACNA, ISPE, FDA , and OSHA. + Capability to conduct advanced field surveys and support field… more
- ThermoFisher Scientific (Greenville, NC)
- …(Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Office **Job Description** **Job Title: Senior Manager, ... Ensure platform compliance with healthcare regulations including HIPAA, CLIA, IVDR, FDA , and GLP. + Work cross-functionally with product management, R&D, Commercial,… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... control systems on automated pharmaceutical packaging equipment + Experience with GMP documentation requirements and have experience with completing batch packaging… more
- Mentor Technical Group (Durham, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... maintenance to minimize downtime. + Ensure HVAC systems comply with GMP , safety standards, and industry regulations. + Troubleshoot system malfunctions and… more
- Mentor Technical Group (Durham, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... Knowledge of mechanical, electrical, and instrumentation systems. + Familiarity with GMP compliance, safety protocols, and documentation requirements. + Ability to… more
- Mentor Technical Group (Durham, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... food manufacturing). + Strong knowledge of NEC codes, safety regulations, and GMP compliance. + Ability to read and interpret blueprints, schematics, and technical… more
- Cambrex High Point (Durham, NC)
- …to read and execute compendial methodologies + Strong understanding of current FDA and cGMP regulations + General knowledge of chemistry and scientific calculations ... + Aptitude and willingness to gain more skills and knowledge in support of GMP regulations + Good written and verbal communication skills + Familiarity with computer… more
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