- Herbalife (Winston Salem, NC)
- …effectively verbally and in written English + Computer literacy, with solid PC and software experience + Ability to lift a minimum of 30 lbs + Strong ability ... this position. **Experience:** + A minimum of 1 year of experience in FDA or GMP regulated industry **Education:** + High-school diploma (or equivalent) **PREFERRED… more
- Eliassen Group (Raleigh, NC)
- …actions + Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components **Experience Requirements:** + Ability to ... + Overall understanding of process instructions + Life Science Experience + Software Skills Required: MS Platform Suite, Oracle, Coupa + Functional knowledge of… more
- Lilly (Durham, NC)
- …skills. + Affinity for mastering technical concepts. + Solid understanding of FDA guidelines and CGMP standards. + Ability to effectively communicate (written and ... verbal). + Flexibility and problem-solving skills. + Basic computer skills (desktop software ) are required. **Other Information:** + This role will train on day… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles and CPV. ... be considered for employment. We will also not offer you money to buy equipment, software , or for any other purpose during the job application process. If you are… more
- Deloitte (Charlotte, NC)
- …capabilities to build, deploy, and operate integrated/verticalized sector solutions in software , data, AI, network, and hybrid cloud infrastructure. These solutions ... familiarity with ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND,… more
- Fluor (Raleigh, NC)
- …or healthcare equipment. + Strong understanding of regulatory requirements, including FDA guidelines and ISO standards. + Strong understanding of BIM/3D design ... and project close-out + Practical field experience + Intermediate computer and software skills to include the use of word processing, e-mail, spreadsheet and… more
- Fujifilm (Raleigh, NC)
- …and providing our customers with timely responses. + Works on 3rd party hardware, software , and network related issues that are sold or supported by FUJIFILM. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- ThermoFisher Scientific (Greenville, NC)
- …important regulatory considerations governing adverse event reporting and experience with FDA , EMA and other national and international regulatory authorities + ... of 15-20 lbs. + Ability to access and use a variety of computer software developed both in-house and off-the-shelf + Ability to communicate information and ideas so… 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 ... knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software **Working Conditions & Physical Requirements:** + Ability to discern… more
- ThermoFisher Scientific (High Point, NC)
- …Follow quality standards in accordance with company policy and cGMP and FDA requirements. Understanding of cGxP requirements. + Troubleshoot & support manufacturing ... learn PLC formats with heavy emphasis on Allen-Bradley PLC/HMI hardware and software : SLC, PLC, ControlLogix, and PanelView. + Strong understanding of electrical… more