- Curia (Rensselaer, NY)
- …compliance with all Quality Management Systems and Regulatory Agency requirements (eg, FDA , EMA, MHRA, etc..) for the Rensselaer site. + Conduct investigations of ... industry (preferred in APIs) at USFDA regulated facilities + Broad knowledge of cGMP, FDA and international regulations (eg, 21 CFR 11, 210, 211, 820, EU GMP, ICH… more
- Boehringer Ingelheim (Fresno, CA)
- …System. + Performs all Company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. + ... Previous account management experience. * Various regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company...and knowledge of territory. * Regulations such as EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company… more
- Johns Hopkins University (Baltimore, MD)
- …reviews for IND/IDE sponsor investigators to + Review the available FDA required documentation for completeness and accuracy, + Familiarize sponsor investigators ... with applicable FDA regulations and responsibilities relative to their role and...from the JHU research community regarding institutional policies and FDA regulations. + Provide practical recommendations to implement strategies… more
- Teleflex (Wyomissing, PA)
- …NC resolutions, and audit preparation activities in support of quality system requirements (eg, FDA 21 CFR Part 820, ISO 13485, ISO 17025). * Manage and execute ... and validation. * Demonstrated experience working within quality-regulated environments ( FDA , ISO standards) in medical device, biotech, or pharmaceutical… more
- Cardinal Health (East Hartford, CT)
- …sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (ie FDA , NRC, DOT) to support patient treatment through disease diagnosis, ... compliance with all regulatory standards including EHS, cGMP, Radiation Safety, applicable FDA and pharmacy laws, DOT, and internal policies and interpretations +… 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 ... of education and experience + 15+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on SAP, Laboratory Information… more
- Endo International (Greenville, IL)
- …in accordance with established procedures and regulatory requirements. + Ensures FDA , EU, and International Regulatory inspection readiness through the development ... of chemical, pharmaceutical or bio-pharmaceutical manufacturing. + Strong knowledge of FDA and International regulations and guidance in the area of Quality… more
- West Pharmaceutical Services (Rockford, IL)
- …that supports production needs and meets all applicable GMP, OSHA, and FDA regulatory standards. **Essential Duties and Responsibilities** + Lead a multiple shift ... may be substituted for educational requirements. required and + Experience with FDA regulations in relation to Facilities, Maintenance and Equipment repair required… more
- Actalent (St. Louis, MO)
- …Develop, implement, and maintain Quality Management Systems (QMS) in compliance with FDA , EMA, ICH guidelines, and other regulatory requirements. + Ensure all ... Skills + 7-10 years of experience in Quality Assurance within a FDA /GMP environment. + Bachelor's degree in a scientific field (Life Sciences, Biotechnology,… more
- Mitsubishi Chemical Group (Wilmington, MA)
- …internal, external, and third-party audits, including regulatory inspections by the FDA + Serve as the ISO Management Representative, ensuring audit readiness ... regulations, quality systems, and validation requirements + Proven experience supporting FDA inspections and third-party audits + Excellent written and verbal… more