- 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 ... practices **Preferred Qualifications** + 3+ years of experience in the FDA regulated pharmaceutical manufacturing environment + SAP Certification **Job Location**… more
- Kelly Services (Dallas, NC)
- …impact the company. 2. Independently research regulatory information related to US FDA , USDA, and Canadian and Mexican regulations. 3. Prepare accurate and timely ... and product compliance, labeling, and claims. 4. Strong knowledge of FDA food regulations. 5. Excellent organizational, analytical, and problem-solving skills. 6.… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and/or warehouse, logistics, production manufacturing experience in a regulated industry ( FDA , USDA, NRC) obtained within the last 5 years OR Two ... and/or warehouse, logistics, production manufacturing experience in a regulated industry ( FDA , USDA, NRC) OR Three years of warehouse experience in a… more
- Mentor Technical Group (Monroe, 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 ... biotech, or medical device industry). + Knowledge: + Familiarity with GMP, FDA , and regulatory requirements for packaging operations. + Understanding of Good… more
- American Red Cross (NC)
- …and regulatory standards for Cell Therapy Laboratory operations (FACT, FDA , CLIA), drive process standardization, and support workforce development.** **External ... growth, manage multidisciplinary teams, and maintain compliance with FACT, CLIA, and FDA standards. Develop new theories and solutions, conduct research of emerging… 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