- Lilly (Concord, NC)
- …+ Understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA, or other similar groups + Excellence in; ... electronic, written, and oral communication skills + Strong technical aptitude as demonstrated through previous work or educational accomplishments **Time Commitments, Environment, and Work Authorization** + Ability to wear safety equipment (glasses, shoes,… more
- ThermoFisher Scientific (Greenville, NC)
- …improvements and efficiencies. + Coordinate regulatory inspections performed by the FDA , MCA, and other agencies. + Defend policies, procedures, rationales, and ... methods during regulatory and client audits. + Establish and supervise quality programs and plans, such as validation, QAT, and supplier certification. **Keys to Success:** **Education** + High School Diploma or equivalent required. + Bachelor's degree in… more
- Eliassen Group (Raleigh, NC)
- …applicable. BIG PLUS: Bluetooth experience & Any industry experience that has FDA requirements OR enterprise level company experience and documentation. There will ... be lots of documentation in this role. _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result… 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 ... GMP conditions and distributed, including computerized and automated systems which require qualification and validation for compliance. The commissioning and validation of equipment, facilities, utility systems and computerized systems are intended to verify… more
- Sodexo (Greensboro, NC)
- …+ Calibrate and validate sterilizers in compliance with manufacturer, AAMI, and FDA standards + Maintain detailed service documentation and logs for compliance and ... reporting + Respond to on-site service requests and minimize equipment downtime + Adhere to all hospital safety procedures, including infection control protocols **What We Offer** Compensation is fair and equitable, partially determined by a candidate's… more
- ICON Clinical Research (Salisbury, NC)
- …of pro-active behaviors. + Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. + Ordering ... clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both. + Monitoring and maintaining… more
- Cardinal Health (Raleigh, NC)
- …+ Review marketing materials related to customer services and FDA approved pharmaceuticals. + Review Business Associate Agreements, Confidentiality Agreements ... and Information Security Agreements **_Qualifications_** + 10+ years of experience preferred + Law firm or in-house healthcare experience preferred, including commercial transactions and fraud and abuse compliance expertise + Experience working with Group… more
- Sumitomo Pharma (Raleigh, NC)
- …Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency ... in BASE SAS and R, or other statistical software is advantageous + Effective verbal and writing skills **Education and Experience** + PhD or MS in statistics or biostatistics related field required. + PhD with 0-3 years or MS with 3 years related experience or… more
- GRAIL (Durham, NC)
- …diagnostic activities, ensuring consistency and compliance with relevant GCP, CLIA, FDA /IVDR, and other global diagnostic regulatory requirements. + Serve as a ... resource and subject matter expert on clinical and companion diagnostic regulatory standards and best practices. + Provide leadership, expertise, and guidance in clinical and companion diagnostic compliance to internal and external stakeholders. + Promote a… more
- UNC Health Care (Raleigh, NC)
- …audits and/or regulatory inspections of records and documents (eg FDA , CLGB/NSABP) **Other Information** Other information: **Education Requirements:** * Bachelor's ... degree (BSN) from an accredited school of Nursing. Master's preferred. **Licensure/Certification Requirements:** * RN NC LIC;BCLS * Certification in Specialty and Clinical Research preferred. **Professional Experience Requirements:** * Two years of relevant… more