- University of Maryland, Baltimore (Baltimore, MD)
- …Center to capitalize on pioneering innovation * Contemplate and develop partnerships with FDA in the planning phase of cancer pragmatic trials to maximize the ... potential relevance of our results on governmental policy and/or clinical practice * Expand existing and develop new partnerships between the University of Maryland and Community Leaders in West Baltimore and other regions of Maryland to maximize participation… more
- Bristol Myers Squibb (Bothell, WA)
- …principles." + Experience working in biopharma, cell therapy, Good Manufacturing Practices, FDA regulated, or other regulated environments is a plus." + Proficient ... in Microsoft Outlook, Teams, Project, Excel, SharePoint, and PowerPoint. Smartsheet is beneficial." + Experience applying predictive/waterfall project management processes and methodologies." + Self-starter who can drive small to mid-sized projects forward… more
- BeOne Medicines (Pennington, NJ)
- …drug preclinical, clinical and commercial requirements. + Familiarity with EMA and FDA regulatory requirements. + Effective communication, oral and written, in a ... multi-disciplinary, project-driven work environment. **Supervisory Responsibilities:** + Strategic and tactical planning with ability to convey business relevance to team + Ability to translate strategy into actionable goals and expectations for team members +… more
- HCA Healthcare (West Haven, UT)
- …with standards set forth by accrediting agencies: CAP, JCAHO, CLIA, FDA and CMS. Leads department accreditation preparation. + Oversees quality control/assurance ... programs related to test methodology, protocols, equipment and supplies. Actively participates in Continuous Quality Improvement. + Provides input into the design of workflows, systems and processes and implements corrective action plans for service/quality… more
- Reckitt (Wanamingo, MN)
- …protocols and reports to qualify manufacturing and cleaning processes. + Interacts with FDA when onsite for audit as a subject matter expert. + Leverages knowledge ... of unit operations and engineering principles to effectively troubleshoot processing and equipment issues. + Use business tools to investigate out of specification issues and recommend disposition of material. + Assess and implement improvements for Plant CIP… more
- Bristol Myers Squibb (Devens, MA)
- …cryogenic storage (LN2) is preferred + Experience with health authorities (ie, FDA ) for audit support + Experience and familiarity with electronic systems including ... SAP, and manufacturing execution systems (MES) including Syncade and DeltaV + Safety and Quality mindset; proven ability to build a culture around these values and to communicate critical information clearly and in a timely manner to team and to manager as… more
- University of Miami (Coral Gables, FL)
- …modality including but not limited to: Joint Commission, AHCA, ACR, FL DOH and FDA /MQSA. + Assist with the day-to-day operations within the department. This list of ... duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. CORE QUALIFICATIONS Education: High School diploma or equivalent. Graduate of a Diagnostic Medical Sonography and/or… more
- University of Pennsylvania (Philadelphia, PA)
- …final follow-up. Secure signatures and forward documents/forms (eg, FDFs, PSPs, FDA 1572, etc.) to appropriate destinations; maintain Delegation of Authority log. ... + Participate in research meetings (eg, team, disease-site, etc.) and Sponsor/CRO teleconferences. Provide coverage and support to meet departmental and organizational staffing needs (ie lunches, sick calls, vacations, or when a specific team member's workload… more
- Aerotek (Chaska, MN)
- …** ️ Key Responsibilities** + Follow SOPs, work instructions, and FDA /ISO requirements in English + Independently perform formulation, filling, testing, and ... packaging tasks + Set up, calibrate, and troubleshoot reagent components and instruments + Conduct solution testing (pH, conductivity, density) to meet specifications + Ensure compliance with QSR, GMP, and ISO standards + Collaborate with cross-functional… more
- Bristol Myers Squibb (Summit, NJ)
- …+ BS degree or equivalent experience + Minimum 5 years of experience in FDA -regulated industry with at least 2 years of recent hands-on CSV and implementation ... experience related to manufacturing and laboratory local standalone computerized equipment and systems. **DUTIES AND RESPONSIBILITIES:** **Essential Functions:** Maintains all qualified and validated equipment and systems in compliance with policies,… more
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