- Biomat USA, Inc. (Greenville, NC)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA),… more
- Merck (Wilson, NC)
- …efficiency, or productivity. + Provides technical assistance for quality and regulatory activities including site inspections, preparation of technical documents for ... NDA supplements, FDA observation, and environmental process issues. + Responsible for...policies and Wilson site procedures for safety, quality, and regulatory compliance. + Review literature pertaining to pharmaceutical packaging… more
- United Therapeutics (Research Triangle Park, NC)
- …at all levels of the organization + Demonstrated knowledge of regulatory /compliance requirements, including anti-kickback laws, FDA promotional regulations, ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... successful submission and approval of a drug product by regulatory agencies. This role will provide scientific insight into...GCP, ICH, and PhRMA guidelines + Knowledge of relevant FDA regulations and guidelines + Ability to work independently,… more
- Herbalife (Winston Salem, NC)
- …**HOW YOU WOULD CONTRIBUTE** **:** * Maintain a solid understanding of regulatory and Herbalife guideline requirements. * Resolves day-to-day floor concerns and ... Knowledge of Good Manufacturing Practices, Food and Drug Administration ( FDA ) regulations ( FDA 21 CFR - Part...to learn. **Experience:** * 3-5 years' experience in a quality/ regulatory environment, + 3 years' experience in Quality related… more
- Merck (Durham, NC)
- …Degree in science or related field + Bioworks Certificate (working in an FDA or similar regulated industry) + Applicable mechanical and project management experience ... similar) + Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP) + Demonstrated ability… more
- Lilly (Durham, NC)
- …quality policies and procedures + Understanding of the importance of and requirements of regulatory agencies such as the FDA , OSHA, and EPA + Demonstrated ... automation KPIs and equipment utilization. + Follow all GMP, and other regulatory requirements. Participate in quality initiatives and audits. Compliance to FDA… more
- Lilly (Concord, NC)
- …corporate policies + Solid understanding of the importance of and basic requirements of regulatory agencies such as the FDA , OSHA, and EPA + Demonstrate solid ... to implement safety projects. + Follow all GMP, and other regulatory requirements. Participate in quality initiatives and audits. Provides leadership for… more
- Lilly (Concord, NC)
- …effectively with a cross functional group. + Solid understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and/or OSHA. + ... functional groups + Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert...2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + Aseptic… more
- Lilly (Concord, NC)
- …SAP/EWM preferred. + Solid understanding of the importance of and basic requirements of regulatory agencies such as the FDA , EMEA, OSHA and EPA. + Demonstrated ... representatives to implement safety projects. + Follow all cGMP, and other regulatory requirements. Participate in quality initiatives and audits. Compliance to … more