- Catalent Pharma Solutions (Greenville, NC)
- …documented in equipment and room logbooks, accurately and compliant with SOPs and FDA cGMP guidelines + Disassembly of dirty equipment before and during cleaning. + ... Assembly of cleaned equipment parts, per Work Instructions. + Assist with setups and changeovers with adherence to SOPs and safety requirements. + Attendance at morning Tier meeting to understand and follow up on daily room and equipment cleaning needs. +… more
- Novo Nordisk (Durham, NC)
- …one (1) year of experience in pharmaceutical solid dose manufacturing or other FDA regulated industry preferred + Ability to read, write & understand complicated ... product documentation & standard operating procedures with attention to detail required + Computer literacy including use of Microsoft Office suite programs required + Basic mechanical skills preferred We commit to an inclusive recruitment process and equality… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …requirements; ie Good Clinical Practice ( GCP ), Food and Drug Administration ( FDA ) regulations and International Conference on Harmonization ( ICH ) guidelines. + ... At least 2 years of clinical trials experience. + Comfort interacting with internal and external stakeholders and the ability to successfully collaborate with multidisciplinary groups of colleagues. + Excellent customer service skills and good judgement are… more
- Catalent Pharma Solutions (Greenville, NC)
- …+ Compile and maintain all information and document relevant to all work under FDA guidelines. + Other duties as assigned. **The Candidate** + Associate degree in ... technical or life sciences discipline with at least five years of mechanical experience required or; + High school diploma or equivalent with at least seven years of mechanical experience required. + At least 2 years of packaging experience required. + Ability… more
- ZOLL Medical Corporation (Greenville, NC)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. ZOLL has been… more
- Grifols Shared Services North America, Inc (Kannapolis, NC)
- …interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and ... compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Performs basic document review and employee observations. Communicates openly with the CQM on issues noted… more
- 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 ... GMP Quality Assurance and/or similar role * Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software **Working Conditions & Physical Requirements:** + Ability to discern audible cues + Ability to… more
- Affordable Care (Kinston, NC)
- …insertions + Tally time sheets in an accurate and timely manner and give to FDA for dentist approval and signature + Assist treating dentist with surgery + Take and ... develop x-rays as needed (has certification, where certification is required) + Consistently sterilize instruments with minimal direction, including impression trays and hand piece burs and wipes down equipment after each patient + Escort each patient to the… more
- Catalent Pharma Solutions (Greenville, NC)
- …preventive maintenance, and calibration) to ensure they are compliant with SOPs and FDA cGMP guidelines through data analysis. + With close supervision, assist in ... the development of timelines and project plans. + All other duties as assigned. **The Candidate** + Current or recent enrollment in a community college or university in an Engineering, Industrial Technology or related degree program required. + Auto CAD… 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:** Baseline Qualifications: + Bachelor's Degree, Trade School Certification (Industry related), or Industry Experience Equivalent + One or more industry-specific certifications in relevant… more