- Univar Solutions (Jamestown, NC)
- …and preparing branch prior to external Compliance and Quality Audits (Customer, Supplier, FDA or other Agencies, and Associations) + Writing SOPs and creating local ... required. + Prior Quality Assurance, Quality Control, Compliance, or Regulatory experience preferred. + Experience in Manufacturing, Operations, Packaging, or… 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 ... procurement operations function operates in full compliance with health, safety, and regulatory requirements + Ensure that all requests for processing are fit for… more
- United Therapeutics (Raleigh, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Conduct field rides within field regions with direct reports to evaluate regulatory compliance and abilities to deliver 'best in class' training and education +… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Duties include: Under the direct supervision of the ... interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and… more
- Fujifilm (Holly Springs, NC)
- …efficiency * Participates in optimization or improvement initiatives and support regulatory agency and third‐party inspections * Performs other duties as assigned ... in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. * High level of familiarity/understanding of validation of… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA /Grifols Quality Systems are adhered to throughout the evaluation, review and ... and cGMP issues. + Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: + Write test cases to validate… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations + Provide assistance with the review and revision of ... OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + Ability… more
- Merck (Wilson, NC)
- …+ Conforms to established safety procedures in accordance with OSHA and other regulatory agencies + Recognizes, utilize, and enforces the use of safety equipment ... a vaccine, pharmaceutical, or GMP regulated environment + Experience within cGMP, FDA , regulated industry experience highly preferred + Packaging & Filling (BFS)… more
- Stantec (Raleigh, NC)
- …related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in ... in conformity with specifications, design intent and client/user and regulatory requirements. Working under the guidance of Director of commissioning/validation,… more
- Sodexo (Greensboro, NC)
- …proactive approach to threat mitigation, and a deep understanding of healthcare regulatory requirements. **What You'll Do** + Lead the collection of critical ... of CMMS platforms, cybersecurity frameworks (eg, NIST, ISO), and FDA /Joint Commission regulations. + Experience collaborating with clinical engineering, IT,… more