- Lilly (Concord, NC)
- …other regulatory requirements. Participate in quality initiatives and audits. Compliance to FDA , EMEA, DEA, OSHA, IDEM, EPA and other applicable regulations. + Meet ... of the importance of and basic requirements of regulatory agencies such as the FDA , EMEA, OSHA and EPA. + Demonstrated solid judgment and initiative. + Ability to… more
- ALBEMARLE (Charlotte, NC)
- …the requisite authorizations under Americas chemical control regulations (eg, TSCA, FIFRA, FDA , etc.) before and while doing business in markets where such programs ... all applicable product regulatory programs, such as: Canada, Mexico SA, TSCA, FDA , EPA, Hazard Communication and their analogues on a country-by-country basis for… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices. Personnel in this position will: + Follow ... 0 - 2 Years experience in CGMP Operations Background Knowledge & Skills: FDA /CGMP/ Mechanical Aptitude START YOUR APPLICATION… 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 ... overseeing work order activity compliance with respective regulatory requirements (ie FDA , DEA, OSHA). + Manage Work through the Computerized Maintenance Management… more
- Cambrex High Point (Durham, NC)
- …and (where required) development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity, and impurities by ... of cGMP requirements.* Strong understanding of basic lab techniques* Good understanding of FDA , EU and ICH requirements and implementation for GLP and GMP in the… more
- Canon USA & Affiliates (Raleigh, NC)
- …of reportable events + Provide information as requested for the filing of FDA recalls + Coordinate FMI process, including monitoring and reporting status and ... requirements/actions + Assist in maintaining proper preparedness for State or Federal ( FDA ) authorities + Represent interests of RA in cross functional teams as… more
- Astellas Pharma (Sanford, NC)
- …and reports. + Assist in the preparation and hosting of regulatory (eg FDA , EMA, DHHS, etc.) inspections as needed. **Required Qualifications** + BS degree in ... utilities, automation, sterile filling, and clean facilities. + Strong understanding of FDA , EMA, local regulations and guidelines, ICH guidelines, and industry best… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Critical Investigations to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct. + ... the Stability and Quality Control departments. + Represent Glenmark as appropriate in FDA , notified body, internal and other regulatory audits. + Work in close… more
- Kelly Services (Durham, NC)
- …High School Diploma required + 1-3 manufacturing experience in a FDA -regulated manufacturing experience preferred + BioWorks certification highly preferred + Ability ... to meet physical requirements including moving/lifting equipment up to 33 pounds and being on your feet for up to 12 hours + Comfortable occasionally working in cold, loud, or outdoor environments with odorous or hazardous materials As part of our promise to… more
- United Therapeutics (Research Triangle Park, NC)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many… more