- ThermoFisher Scientific (Greenville, NC)
- …Quality Validation: Govern validation activities for equipment, processes, computer software , and cleaning validation, ensuring compliance with industry standards ... experience with automated testing frameworks, and strong understanding of software development life cycle (SDLC). + **Analytical Skills:** Excellent problem-solving… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …legal and regulatory components of the pharmaceutical and biotech industries (eg, FDA regulations, Anti-Kickback Statute, HIPAA) + Valid driver's license and ability ... 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
- BioFire Diagnostics, LLC. (Durham, NC)
- …utilize SOP and documentation to record data manually or through identified software applications. + Safety + Comply with all safety policies and procedures ... OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + Ability… more
- Dentsply Sirona (Charlotte, NC)
- …documentation, including 510(k) submissions and CE marking + In-depth knowledge of FDA regulations and international standards (eg, ISO 13485) **Key Required Skills, ... Capabilities:** + Proficiency with Microsoft Office Suite + Proficiency with Regulatory software + Strong leadership, attention to detail and organizational skills +… more
- Cambrex High Point (High Point, NC)
- …to read and execute compendial methodologies + Strong understanding of current FDA and cGMP regulations + General knowledge of chemistry and scientific calculations ... + Good written and verbal communication skills + Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel. + Aptitude… more
- Compass Group, North America (Charlotte, NC)
- …wellness related programs and initiatives and to ensure compliance with FDA nutrition labeling laws. **Key Responsibilities:** + Coordinates and implements sector ... twelve (12) weeks from date of hire. + Familiarity with nutrition analysis software is preferred. + Culinary and/or foodservice experience preferred. **Apply to Bon… more
- Merck (Wilson, NC)
- …Skills:** * Relevant work experience encompassing a working knowledge of FDA regulatory requirements * cGMP experience in a pharmaceutical manufacturing, packaging, ... skills using advanced functionality in excel, Parsec, Microsoft access, statistical software packages (Minitab) * Demonstrated ability to coach others in performance… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …**Qualifications** + Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of ... 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
- Actalent (Wilson, NC)
- …management, or a related role. + Knowledge of regulatory requirements (eg, FDA , EMA) and industry standards. + Strong analytical and problem-solving skills. + ... skills. + Proficiency in quality management systems (QMS) and relevant software tools. Additional Skills & Qualifications + Certification in Quality Management… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …information (eg, Lot, Expiration Date, Date of Manufacture, Potency) using various software (ie EasyLabel, etc.) * Establishes controlled label copy, master files ... Strong knowledge of compliance standards with the Food Drug Administration ( FDA ), international governing entities and Good Manufacturing Practices (GMPs) +… more