- Astrix Technology (Chino, CA)
- …Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and relevant FDA regulations while maintaining accurate documentation and coordinating with ... school diploma or equivalent certification. + Solid grasp of cGMP, GDP, and FDA requirements as they relate to material sampling operations. + Exceptional attention… more
- Stanford Health Care (Palo Alto, CA)
- …Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off-label use) ... require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room. The RN First Assistant directly assists the surgeon and practices under the supervision of the… more
- Cordis (Miami Lakes, FL)
- …process validation (IQ/OQ/PQ) activities, ensuring compliance with ISO 13485 and FDA QSR requirements. + Troubleshoot and resolve extrusion process issues, ensuring ... setup. + Experience with cleanroom manufacturing and compliance to ISO 13485 and FDA 21 CFR Part 11/QSR. + Proficiency with statistical analysis tools and process… more
- Cambrex High Point (Longmont, CO)
- …equipment by following standard operations procedures and batch records in accordance with FDA cGMPs. The main focus for personnel in this position will be ... out-of-specification conditions. + Ability to work in a regulated environment ( FDA /DEO/OSHA) and strictly follow procedures. + Effectively communicates both verbally… more
- University of Utah (Salt Lake City, UT)
- …negotiating study contract budget and payment terms. 13. Maintain documents as required by FDA , ICH , GCP , and IRB regulatory guidelines. 14. Maintain contact with ... and effective communication skills also required. Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of research procedures; and… more
- Integra LifeSciences (Plainsboro, NJ)
- …all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... Clean Room gowning. + Batch manufacturing experience. + Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International… more
- Stanford Health Care (Palo Alto, CA)
- …Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off- label ... use) require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room. The RN First Assistant (RNFA) directly assists the surgeon and practices under the… more
- Actalent (Anaheim, CA)
- …with CTMS, particularly Verily/Signal Path or similar systems. + Familiarity with FDA (GCP, ICH guidelines) and other federal, state, and local regulations on ... human research. + Experience in working with pharmaceutical and FDA agency representatives. Additional Skills & Qualifications + Master's degree in Healthcare,… more
- Sanofi Group (Morristown, NJ)
- …the COA team in Sanofi asset and indication strategy meeting, as well as in FDA meetings on invitation. + The Senior COA Lead also takes direct accountability of ... strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local… more
- J&J Family of Companies (Dallas, TX)
- …while professionally representing the company. + Comply with all corporate compliance, FDA , medical device, quality standards and ethics. + Other duties as assigned. ... conjunction with near-term plans to further business goals. + Must not be debarred by FDA for work in any Medical Device business. + Ability to work in a fast-paced… more
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