- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Information Social Media and other suppliers. Develop governance, business continuity, quality , and vendor monitoring plans. Maintain oversight for capability ... deriving from these contracts. Organize and conduct periodic review of contract quality and adherence. Support business functions in determining PV relevance for… more
- Aequor (Bothell, WA)
- …presentation of department metrics includes input into reports to Management, annual product quality reviews and process monitoring 5. Assign part and lot ... batch record reviews d. GMP incident/deviation review 2. Apply the principles of good quality systems and GMP, as assigned on a daily basis 3. Create and revise… more
- Aequor (Thousand Oaks, CA)
- …monthly measurement of Quality Control and Retrospective QA metrics Oversee performance monitoring and relay quality metrics to vendors Analysis of QC trends ... of all case intake and processing activities and case quality including analysis and reporting of trends in ...quality including analysis and reporting of trends in quality measures Ensure vendor compliance with approved processes and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Quality Compliance Lead as part of the Quality team based in Raritan, ... the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit...required, run reports and conduct data analysis to support monitoring of key performance indicators; support the preparation of… more
- Novo Nordisk Inc. (WA)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Insmed Incorporated (San Diego, CA)
- …primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies.Medical monitoring , coding, and data ... development team. This individual will be the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... and oversee performance of CROs, third party vendors, and contractors, including co- monitoring , to ensure compliance with study protocol, and identifying areas of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Microbiology Data Reviewer is ... for reviewing microbiology data and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing… more
- Merck & Co. (Fort Wayne, IN)
- …health care providers such as physicians, nurses, pharmacists as well as quality directors, immunization managers, and office managers. Within their geography there ... patient health outcomes, customer feedback, marketplace dynamics, and progress towards quality goals.Providing customers with key insights by keeping apprised of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …team of manufacturing professionals and performing aseptic interventions, environmental monitoring , and other microbiology and operational tasks. This newly created ... equipment issues when necessary. Address and escalate manufacturing, sterility, or quality concerns to the appropriate department leaders. Develop and implement… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control ... coach cross functional team staff in areas such as quality , compliance, safety, project planning, process development, technology development.Communicate effectively… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new ... Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality , and other affiliates. External stakeholders include Healthcare professionals,… more
- Eisai, Inc (Nutley, NJ)
- …risk framework.Control Gaps: Identify and manage IT compliance control gaps. Monitoring Programs: Develop programs to manage IT compliance-related risks.Issue ... external audits.Awareness Training: Promote IT compliance awareness training programs.Performance Monitoring : Define KPIs and monitor IT compliance metrics.Incident Response:… more
- Eisai, Inc (Nutley, NJ)
- …reviews, reconciliation and study file archival Performs detailed eTMF CRO quality check reviews with follow-up for missing documentation under the supervision ... preparation and follow-up ( eg Informed Consent Form, eTMF fling plan, Co- Monitoring Plan) Creates Clinical Trial Agreement requests using the legal tracker and… more
- Merck & Co. (North Wales, PA)
- …as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Merck & Co. (Durham, NC)
- …5S, kaizen events, or any other operations, lean six-sigma, quality , safety or environmental training/initiatives as required. Operational Expertise Competent ... supporting Process Support operations:Aseptic BehaviorsAseptic Techniques & ManipulationscRAB/Isolator ExperienceEnvironmental Monitoring #MSJR Current Employees apply HERE Current Contingent Workers apply… more
- Merck & Co. (OK)
- …as physicians, physician assistants, nurse practitioners, nurses, pharmacists as well as quality directors and office managers.-- Within their geography there are a ... patient health outcomes, customer feedback, marketplace dynamics, and progress towards quality goals.Providing customers with key insights by keeping apprised of… more
- Merck & Co. (TX)
- …as physicians, physician assistants, nurse practitioners, nurses, pharmacists as well as quality directors and office managers.-- Within their geography there are a ... patient health outcomes, customer feedback, marketplace dynamics, and progress towards quality goals.Providing customers with key insights by keeping apprised of… more
- Merck & Co. (Rahway, NJ)
- …cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends ... microbioreactor systems, and advanced in situ analytics for process monitoring and control.Experience with state-of-the-art cell culture processes including… more
- Eisai, Inc (Raleigh, NC)
- …more ESI managed products. Works in close collaboration with the Raleigh based Quality and SCM Units to assure timely completion of defined project technical ... in and promotes hhc and compliance activities.Lead process performance monitoring , operational excellence activities, and process improvement strategies.Works with… more
