- Fujifilm (Holly Springs, NC)
- …project-driven organization + Experience in a CGMP facility or working with FDA regulations Preferred Qualifications: + Prior experience in a similar role in ... large projects from conceptual design phase to operations + 4+ years of experience leading and developing leaders + Experience leading manufacturing or technical departments Physical Requirements: + May work in Mechanical/Production spaces that may require… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + All other functions and or responsibilities that may be assigned by management. **Qualifications:** + Associate degree in computer science or related field, or equivalent work experience. + Minimum of 4… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill, and/or… more
- Insight Global (Winston Salem, NC)
- …independently in accordance with departmental policies and regulatory standards ( FDA , FACT), administering pre-transplant conditioning and pre-CAR T lymphodepleting ... chemotherapy, and completing hematopoietic cell transplants and cellular product infusions. This nurse also manages and maintains venous access throughout treatment and monitors patients daily following transplant and CAR T therapy to ensure safety and optimal… more
- Corning Incorporated (Durham, NC)
- …+ Minimum of 6 years' experience with equipment maintenance in an FDA compliant manufacturing environment. + Specific work experience required in use of ... Vision systems, electrical troubleshooting of circuits from low level signals up to 480 VAC, Allen-Bradley Programmable Logic Controllers (PLCs), and making modifications to Ladder Logic. **This position includes significant duties such as:** + Coordinates… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …requirements + Strong knowledge of global regulatory and compliance standards ( FDA , EFPIA, IFPMA, PhRMA) + Proven track record of proactive, entrepreneurial ... work style + Excellent communication, executive presentation and collaboration skills + Demonstrated ability to deliver exceptional customer service and build strong relationships with internal and external stakeholders, ensuring a positive and professional… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements, and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience: + 8+ years of progressive… more
- Fujifilm (Holly Springs, NC)
- …experience * Experience in cGMP manufacturing operations and/or Quality role in an FDA /EMA regulated facility. * Experience and working knowledge of ICHQ7 and 21CFR ... part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines. * Experience collaborating and interacting with a global team. * Training and/or familiarity with Quality Risk Management principles **Preferred Requirements:** * 10+ years' experience in a GMP… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience + 4+ years previous sales… more
- Novant Health (Winston Salem, NC)
- …policies and procedures, as well as regulatory requirements (ex. FDA , FACT). + Administers pre-transplant conditioning chemotherapy regimens and pre-CAR ... T lympho-depleting chemotherapy. + Performs hematopoietic cell transplantation and cellular product infusions. + Maintains and cares for patient venous access used during apheresis procedure. + Monitors patients daily post-transplant and post-CAR T.… more