- Procter & Gamble (Brown Summit, NC)
- …sync with Good Laboratory Practice (GLP) and current Good Manufacturing Practice ( cGMP ). The work will require collection, labeling, analysis, and results recording ... disposition, facilitate or participate on quality system failures investigations. Maintain cGMP principles and Good Documentation practices. Where do you fit in?… more
- Quality Consulting Group (Holly Springs, NC)
- …the floor in Services area and are responsible for the manufacturing of cGMP (current Good Manufacturing Practices) drug substance. + Completes work in accordance ... with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal… more
- Lilly (Durham, NC)
- …procedure management, review of specifications, review and approval of cGMP documents, and maintaining regulatory compliance. **Responsibilities:** + Support the ... On-site presence required. **Additional Skills/Preferences:** + Demonstrated understanding of cGMP regulations. + Previous experience in GMP production environments.… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …recommending and implementing innovations where appropriate + Ensure compliance with cGMP regulations and other relevant quality standards + Represent the MSAT ... scale-up, and technology transfer of biologics products + Strong knowledge of cGMP regulations and ICH guidelines relevant to biologics manufacturing + Experience… more
- Fujifilm (Holly Springs, NC)
- …for operational readiness objectives and QA support ofmanufacturing operations in cGMP regulated facility * Participate in streamlining or efficiency improvement ... 1-3 years' experience in a GMP environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility… more
- ThermoFisher Scientific (Holly Springs, NC)
- …processes, cross-functional projects, or strategic account management. + Familiarity with cGMP , regulatory compliance, and supply chain operations in biopharma. + ... of biopharmaceutical production, supply chain, and regulatory requirements (eg, cGMP etc.). + Familiarity with chemical manufacturing processes and bioproduction… more
- ThermoFisher Scientific (High Point, NC)
- …the Life: + Follow quality standards in accordance with company policy and cGMP and FDA requirements. Understanding of cGxP requirements. + Troubleshoot & support ... blueprints, schematics, manuals and technician papers. Preferred: + Experience in a cGMP environment. + Minimum knowledge and ability to learn PLC formats with… more
- Reckitt (Wilson, NC)
- …executed efficiently, safely, and in compliance with all regulatory, quality, and cGMP standards. The manager is accountable for delivering daily performance goals ... corrective actions documented in SPIN. + Maintain full compliance with cGMP , FDA, and internal quality standards, overseeing batch documentation, deviation… more
- Fujifilm (Holly Springs, NC)
- …1:1s on a defined cadence with direct reports + Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training + ... manufacturing run cadence and order of shift activities. You have expertise in cGMP , safety and FDBN operational procedures. You have a strong cross functional… more
- Fujifilm (Holly Springs, NC)
- …procedures, and processes for QA support of manufacturing operations in cGMP regulated facility * Ensures operational quality objectives are met within ... in GMP Quality Assurance and/or similar role * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. *… more