- Biomat USA, Inc. (Research Triangle Park, NC)
- …+ Coordinates and organizes final responses to regulatory inspections / audits ( FDA , EMA, CLIA/COLA, PPTA, State, Health Canada, internal compliance audits). + ... Supports donor centers with customer audits, completes requested customer-driven documents, and assists with development of audit responses. + Ensures donor center and corporate operations are compliant with Domestic / European regulations through routine… more
- BrightSpring Health Services (Washington, NC)
- …therapy guidelines, medication safety practices, and regulatory standards (CMS, DEA, FDA ). + Proficiency in electronic medical records and pharmacy information ... systems + Strong clinical judgement, and effective written and verbal communication + *Position will be posted for a minimum of 7 business day About our Line of Business PharMerica, an affiliate of BrightSpring Health Services, delivers personalized pharmacy… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …programming infrastructure is robust, scalable, and compliant with regulatory standards (eg, FDA 21 CFR Part 11, GxP), and supports reproducibility and audit ... readiness. + Promote automation and standardization of programming workflows to improve efficiency and consistency across studies. **Project Delivery & Resource Management** + Accountable for the timely and quality completion of all programming deliverables… more
- Parexel (Raleigh, NC)
- …specimen requests, and verify part numbers for correct submissions. + Ensure FDA Section 508 accessibility compliance on US labels. **Global Implementation & Health ... Authority Engagement** + Support regional implementation of CDS updates and monitor compliance across markets. + Partner with regional and local regulatory leads to address Health Authority inquiries and manage country-specific labeling variations. + Prepare… 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 ... 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
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …+ Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver impactful learning programs ... using adult learning principles. + Experience with learning technologies (eg, LMS, virtual learning platforms) and data-driven training strategies. + Proven experience designing and implementing global training programs for Commercial and G&A functions. +… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and mastering manual and automated testing procedures conducted within an FDA regulated GMP/GLP environment. Performs biological testing of moderate to advanced ... complexity within the QC Biochemistry Laboratory. Manual Laboratory testing methods revolve around 96 well, plate-based testing, using single and multi-channel pipettes for serial dilutions. Other testing procedures involve automated analyzers for… more
- Fujifilm (Holly Springs, NC)
- …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 equipment modifications and… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications** + Bachelor's degree in related technical field or accredited NDT certification, or equivalent NDT work experience within the Oil and Gas industry. + Minimum 5 years' sales and customer… more
- Sysco (Charlotte, NC)
- …years meat and/or seafood industry (as appropriate) experience at a federal CFIA/ FDA meat and/or seafood processing plant (as appropriate). Knowledge of meat, ... poultry and/or seafood products including product specifications. Experience as a Quality Assurance or Quality Control Technician in a meat or seafood processing is desirable. **LANGUAGE SKILLS:** Incumbent must demonstrate ability to write reports, basic… more