- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the business strategy.Lead the PV inspection management activities by ensuring readiness , compliance, and inspection preparedness for the respective PV inspections ... CSPV teams, including the quality risk assessments and inspection readiness components for the designated programs.Ensure proactive representation of Quality… more
- Merck & Co. (Rahway, NJ)
- …Safety and Environment (S&E) and GMP requirements as well as ensuring facility readiness for batch processing. In addition, this position is expected to work ... are not limited to: Lead, prepare for and/or support batch processing readiness and execution activities. Prepare, review, and/or approve GMP Documentation as… more
- Banner Health (Phoenix, AZ)
- …No call requirementsThis position Demonstrates accountability for operating room readiness ensuring sterile surgical instrumentation and disposable supplies are ... team with limited supervision. Demonstrates accountability for operating room readiness ensuring sterile surgical instrumentation and disposable supplies are… more
- Merck & Co. (Rahway, NJ)
- …including upstream, analytical, and secondary manufacturing and GMP site readiness .Actively interacts with internal and external counterparts.- Represents functional ... development, process characterization, process performance qualification and validation, site readiness , batch record reviews, authoring regulatory BLA sections and… more
- Merck & Co. (Durham, NC)
- …of coaches, production specialists, and operators through commercial production readiness initiatives supporting the HPV vaccine franchise expansion. This leader ... strategies to maintain a high-performance learning organization Manage operational readiness project priorities, timelines, and resource allocation to achieve a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Health Authorities. Ensure compliance with international regulations. Ensure inspections readiness as well as prepare potential audits linked to assigned ... to optimize Statistics technology, processes, and standards (improving quality/inspection readiness , decreasing cycle times, and reducing costs). Qualifications: Successful… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaborate closely with Operations Associates and Management to facilitate readiness of trainees and effective process qualifications. The role will require ... relevant cross functional groups to enable robust training, regulatory compliance, team readiness , and processing of product prior to release to patients. Key… more
- Banner Health (Casper, WY)
- …Wyoming.POSITION SUMMARYThis position demonstrates accountability for operating room readiness ensuring sterile surgical instrumentation and disposable supplies are ... replacement of surgical instruments to maintain the inventory and support readiness of sets.5. Utilizes specialized equipment for the decontamination, high-level… more
- Banner Health (Gilbert, AZ)
- …team with limited supervision. Demonstrates accountability for operating room readiness ensuring sterile surgical instrumentation and disposable supplies are ... replacement of surgical instruments to maintain the inventory and support readiness of sets. 5. Utilizes specialized equipment for the decontamination, high-level… more
- Banner Health (Gilbert, AZ)
- …care.POSITION SUMMARYThis position demonstrates accountability for operating room readiness ensuring sterile surgical instrumentation and disposable supplies are ... replacement of surgical instruments to maintain the inventory and support readiness of sets.5. Utilizes specialized equipment for the decontamination, high-level… more
- Banner Health (Mesa, AZ)
- …team with limited supervision. Demonstrates accountability for operating room readiness ensuring sterile surgical instrumentation and disposable supplies are ... replacement of surgical instruments to maintain the inventory and support readiness of sets. 5. Utilizes specialized equipment for the decontamination, high-level… more
- UNC Health (Chapel Hill, NC)
- …discharge of the patient and any care that will assist with discharge readiness . Modify discharge plan based on information shared at the meeting. Assist with ... throughout the day to ensure appropriate progression of care. Identify patient's readiness to discharge based on discussions with the patient/family/care team on an… more
- The University of Vermont Health Network (Burlington, VT)
- …regulatory program to assure that an effective and comprehensive regulatory and accreditation readiness program is in place. This program includes but is not limited ... the Regulatory Coordinator is responsible for implementation of key regulatory readiness strategies that promote effective compliance with state and federal… more
- Merck & Co. (Durham, NC)
- …interpersonal, leadership, and collaboration skills responsible for supporting Operational Readiness projects and initiatives for a new manufacturing facility. This ... role will contribute to the overall performance and results of a E2E drug substance department. Responsibilities may include but are not limited to; Partnering with the Operations management team to create and execute strategies that support design,… more
- Merck & Co. (Durham, NC)
- …interpersonal, leadership, and collaboration skills responsible for supporting Operational Readiness projects to support biological processes for a new manufacturing ... facility or currently established manufacturing facility. This role will contribute to the performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will be required based on business unit… more
- Eisai, Inc (Nutley, NJ)
- …issue resolution.Report compliance risk levels to key stakeholders.Coordinate audit readiness and resolution.Align IT compliance budget with risk appetite and ... global strategy.Educate end-users on IT compliance requirements.Oversee business continuity, disaster recovery, and crisis management.Manage IT training programs and conduct Segregation of Duties reviews.Regulatory Compliance Activities:Collaborate with legal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents filed by the RD Procurement team, periodically, to ensure audit readiness . Review interpret stored documents show appropriate information and follow up ... directly with individuals to close any gaps. To prepare for an Inspection, first step is to create a Vendor List for the scope of the inspection. Work with Cross-functional team of Procurement, QA, Stakeholder Leads, to ensure all required vendors and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the assigned GMA plan activities, in collaboration with Sr Director.Support medical readiness activities for market launches and life cycle management for select ... indications/projects. Gains strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide medical support/input into commercial and market access discussions for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stakeholders to optimize technology, processes, and standards (improving quality/inspection readiness , decreasing cycle times, and reducing costs)- Any other duties ... deemed pertinent to the needs of the business.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sciences, and risk management tools and resources.- Risk Management Compliance Inspection Readiness Champion. Serve as member of Risk Management office to ensure ... risk management activities allow for effective preparation for inspections/audits. Serve a key support during Risk Management Inspections.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
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