- Bridgestone Americas (Nashville, TN)
- …that impact the company's business, including OGA requirements such as NHTSA, FDA + Manage North American FTA qualification program, including NAFTA/USMCA compliance ... and audits. + Ensure Duty Drawback program is managed effectively and compliantly + Manage two Foreign Trade Zones in the US **Essential Skill and Abilities** + Ability to develop and write clear and concise processes and procedures. + Self-starter with strong… more
- United Therapeutics (VT)
- …their 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 others is an… more
- Norstella (Nashville, TN)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient,… more
- Parexel (Nashville, TN)
- …of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc. ... or a related medical role is required. _Depth of experience will be considered when determining the level of Senior Vice President Technical or Vice President Technical_ + Extensive Endocrinology, Neuroscience, Rare Disease, or Immunology experience is… more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- …operations. * Both working and theoretical knowledge of ICH GCP Guidelines, FDA CFR, PhRMA code, site management, and regulatory compliance. * Excellent written ... and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors and consultants. * Possess advanced computer skills (eg, Microsoft applications, etc. * Financial management skills as applicable to… more
- Lilly (Lebanon, IN)
- …**Additional Preferences:** * Experience in pharmaceutical, biotechnology, or other FDA -regulated industries with deep understanding of cGMP data integrity ... requirements and regulated manufacturing data environments. * Track record of technical innovation demonstrated through publications, patents, conference presentations, open-source contributions, or recognized achievements in advancing data management… more
- Cleveland Clinic (Cleveland, OH)
- …and quality. + Improves manufacturing processes and workflows. + Adhere to cGMP, FDA , FACT and Cleveland Clinic policies and guidelines. + Develop in-depth expertise ... for all regularly performed activities and share knowledge within the team. + Lead by example to create a strong culture of safety, quality and continuous improvement within the team. + Complete assigned training and continuing education activities. Minimum… more
- Medtronic (MN)
- …to read and understand schematics and engineering drawings. + Familiar with the FDA 21 CFR, CGMP for Medical devices. + Excellent analytical and communication skills ... with the ability to communicate complex technical issues in an easy to understand manner. + Responsive problem solver and action oriented in resolving customer issues and meeting customer requirements. + Experience with x-Ray systems particularly mobile… more
- Chobani (Philadelphia, PA)
- …Quality & Food Safety Ensure all products meet or exceed SQF, HACCP, FDA , and internal quality standards. Partner with the Quality team to investigate issues, ... implement CAPAs, and maintain audit readiness. Supply Chain & Inventory Coordinate with Procurement and Planning to ensure raw materials (green coffee, packaging, ingredients) are available to support production schedules. Oversee inventory accuracy, material… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …**Experience:** 1. 4+ years' experience in Manufacturing, Pharmaceutical or other FDA licensed Industry or documented and demonstrated abilities to meet requirements ... through the department curriculum based qualifications is required. 2. Forklift certification 3. Experience in reading, understanding, and following Standard Operating Procedures **Responsibilities:** 1. Coordinate and distribute daily workload 2. Assist in… more