- Biomat USA, Inc. (Jacksonville, NC)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. + Attend… more
- Mentor Technical Group (Durham, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... principles, cleanroom classifications, and sterile technique. + Familiarity with GMP, FDA , and regulatory requirements for sterile manufacturing. + Knowledge of… more
- Datavant (Raleigh, NC)
- …and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). + Represent Datavant's quality program ... software organizations. + Strong working knowledge of relevant regulations and frameworks, including ** FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA** ,… more
- United Therapeutics (Morrisville, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... testing, and registration and annual stability programs + Knowledgeable of FDA cGMP requirements and familiar with USP testing requirements for pharmaceutical… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + Monitor training compliance ... + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver impactful learning programs… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... with a Bachelor's Degree + Prior experience working in an FDA regulated pharmaceutical manufacturing environment + Prior experience working on construction… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... with a Bachelor's Degree + Prior experience working in an FDA regulated pharmaceutical manufacturing environment + Organizational skills including, but not… more
- Norstella (Raleigh, NC)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... concepts + Experience in using research tools and databases (eg, ClinicalTrials.gov, EMA, FDA , SEC filings) + High proficiency in MS Office Suite (Excel, Word,… more
- Compass Group, North America (NC)
- …programs that meet or exceed global regulatory requirements (OSHA, ISO 45001, FDA , USDA, EU directives, Codex Alimentarius) and client-specific standards. + Partner ... of international safety and food safety standards and frameworks (OSHA, ISO 45001, FDA , USDA, EU and APAC regulatory systems). + Ability to work effectively across… more
- Grifols Shared Services North America, Inc (Fayetteville, NC)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. + Attends… more