- Kestra Medical Technologies, Inc (Fayetteville, NC)
- …needs * Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra ... Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a … more
- Sumitomo Pharma (Charlotte, NC)
- …relating to product promotion and information dissemination including, but not limited to, the Federal Food , Drug , and Cosmetic Act, the Food and Drug ... Administration's implementing regulations, the Federal Anti-Kickback Statute, the False Claims Act, PhRMA, Corporate Code of Business Conduct and the Office of the Inspector General's Compliance Program Guidance for Pharmaceutical Manufacturers. + The… more
- The Clorox Company (Durham, NC)
- …cosmetic and personal care space. + Strong knowledge of FDA regulations [e.g., The Food Drug and Cosmetic Act (FD&C Act), Modernization of Cosmetics Regulation ... robust compliance program for our personal care and over-the-counter (OTC) drug products. This role independently leads regulatory activities, ensuring compliance… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …and company policies / procedures. **Primary Responsibilities:** + Ensures compliance with Food and Drug Administration (FDA) regulations and all policies, ... change control activities. **Knowledge, Skills and Abilities:** + Strong knowledge of Food and Drug Administration (FDA) regulatory requirements for good… more
- Fujifilm (Holly Springs, NC)
- …site. The Lead ensures compliance with all applicable regulatory requirements, including Food & Drug Administration (FDA), current Good Manufacturing Practices ... (cGMP), and Occupational Safety and Health Administration (OSHA) regulations. **Job Description** **What You'll Do** * Leads a team of I&C technicians through troubleshooting and repairing equipment failures, conducting preventative maintenance, and performing… more
- CSL Plasma (Gastonia, NC)
- …set-up, donor monitoring and donor disconnect. 2 In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to ... begin pheresis process. 3 Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes… more
- Fujifilm (Holly Springs, NC)
- …and verbal *Knowledge of cGMP and European Medicines Evaluation Agency (EMEA) or Food & Drug Administration (FDA) regulations *Proficient in Microsoft Office ... (eg, Word, Excel, PowerPoint, SharePoint) *Ability to analyze and troubleshoot simple to moderate system and component related issues *Ability to effectively present information to others *Willingness to provide feedback to others, including leaders **Required… more
- Fujifilm (Holly Springs, NC)
- …Manufacturing Practices (cGMP) manufacturing operations and/or Quality oversight, in a Food and Drug Administration (FDA) regulated facility. **Preferred ... **Position Overview** The **QA Engineer, Drug Substance Manufacturing (DSM)** is responsible for partnering in the Quality oversight of DSM project processes. This… more
- Parexel (Raleigh, NC)
- …when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + ... adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE… more
- ITG Brands (NC)
- …+ Work experience to include, but is not limited to: + Experience in Food and Drug Administration (FDA) regulated environment + Specification/BoM Maintenance in ... investigation of their background, references, past employment, education, criminal record, and drug screening. Results of such background checks will be reviewed on… more