- 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 ... and creation of reports, etc + Assist with equipment validation activities associated with CGMP process + Assist with...of CGMP regulations + Applied knowledge of pharmaceutical GMPs, FDA guidelines, and industry standards and the ability to… more
- GRAIL (Durham, NC)
- …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... robust performance across all workflow phases. + Develop, optimize, and document validation protocols and procedures in compliance with CLIA, CAP, NYS, ISO 13485,… more
- Medtronic (Mounds View, MN)
- …lifecycle. + Ensure compliance with all relevant regulatory requirements, including FDA , ISO, and other international standards, and participate in regulatory audits ... and inspections. + Oversee validation and verification activities, including the development of test...Advanced degree preferred. + **Regulatory Knowledge:** In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant… more
- University of Miami (Miami, FL)
- …Proficiency: Skilled in using office software, technology, and relevant computer applications. + Communication: Strong verbal and written communication skills ... SOPs are in compliance with relevant rules and regulations such as the FDA , CLIA, state testing requirements, Joint Commission, etc., managing FDA reportable… more
- Terumo Medical Corporation (Elkton, MD)
- …oversee the Automated System Lifecycle definition, design, development, integration, and validation of new or modified manufacturing processes from concept through ... and production issues. d. Ensure all automation and control systems comply with FDA regulations, ISO standards, GMP requirements specific to medical devices and all… more
- Gilead Sciences, Inc. (Foster City, CA)
- …resource, budget, and program milestones. + Working knowledge of lab automation, computer validation , data governance, data science, knowledge management and ... development from early development to commercial launch, filing experience with FDA /EMA, and in-depth technology understanding for biological products are the key… more
- Zimmer Biomet (Englewood, CO)
- …* Proficient in Geometric Dimensioning and Tolerancing (GD&T) preferable * Process Validation experience * Basic Computer Skills (MS Office) **Compensation ... Assisting project teams on compliance with purchasing requirements per FDA QSR, European MDD/MDR, ISO 13485 and other applicable...* Accurately represents quality processes to 3rd party auditors ( FDA , ISO 13485, MDSAP, etc.) * Other duties as… more
- Lactalis American Group Inc. (Buffalo, NY)
- …all LUSA suppliers (Raws & Packs, CoMan) with the Group QFS standards & FDA standard; to ensure Business Continuity & Reputation. Lead the transformation of Q&FS ... no buy" implementation in sourcing. . Manage raw/packaging specifications, including validation , improvement, and annual risk assessment with stakeholders. . Oversee… more
- Catalent Pharma Solutions (Chelsea, MA)
- …manufacturing. The candidate provides support in automation engineering, design, and validation . The Automation Engineer II contributes to the design and ... Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements + Prepares standard operating procedures for new and existing control… more
- Abbott (Minnetonka, MN)
- …Work with design engineering in the completion of product verification and validation + Work with microbiology to ensure appropriate environmental monitoring and ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more