- Repligen (Waltham, MA)
- …Waltham, MA, and will report to the Senior Manager of Supplier Quality .Responsibilities Supplier Performance Monitoring and ReportingCollect, analyze, and report ... OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality , compliance, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring ) sets the vision and strategy for the RBQM function ... within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable… more
- BioAgilytix (Durham, NC)
- …with governance platforms like Collibra or Alation for data cataloging, quality monitoring , and compliance tracking.Preferred Minimum SkillsAbility to execute ... That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can… more
- Aequor (Thousand Oaks, CA)
- …collection, cleaning, and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring , Quality by Design, Risk-based Quality Management ... Deep understanding of Risk Based approaches and its impact with Data Management/Site monitoring operationally - consider the role of both Data Management and Site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …against service level and KPIs.Manage the development of governance, business continuity, quality , and vendor monitoring plans. Maintain oversight for capability ... with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other suppliers.Ensure… more
- Genmab (NJ)
- …authorities or ethics committees, answers to in-house questions related to data quality , safety monitoring , medical questions etc.Performs sponsor oversight of ... consistency and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for decision making.… more
- Twist BioScience (South San Francisco, CA)
- …software and CSV.Experience with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom ... across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated environment. The… more
- Aequor (West Greenwich, RI)
- …collection and sample handling to support GMP operations and Environmental/Water monitoring . 2. Perform testing and possible data review for compendia, non-compendia ... methods, and routine laboratory procedures. 3. Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. 4. Operate and maintain specialized laboratory equipment and instrumentation. 5. Participate in… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product manufacture, test and… more
- Aequor (Cincinnati, OH)
- Quality Control Analyst I Does the position allow for the worker to be virtual/remote? No Temp to Perm: Temp to perm based on openings and performance Shift ... preventive actions Perform routine maintenance on lab equipment as needed Monitoring chemical and dry stock inventory Assist with ordering chemicals/materials… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.-Position Description-This is a… 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
- Aequor (Hicksville, OH)
- …reviewing batch paperwork, performing line clearances, setting up and monitoring all batches. Major Accountabilities Provides direction/line assignments to packaging ... feedback on operator performance. Interacts with production management, mechanics, and Quality Assurance. Participates in training of new employees. Adheres to all… more
- Merck & Co. (Rahway, NJ)
- …implement statistical process control methodologies and data anlaysis to ensure the quality and reliability of autoinjector and syringe products, and other medical ... performance.- Identify critical attributes, and create and implement prospective monitoring plansEnsure data analysis using structured and modern data science… more
- Merck & Co. (Rahway, NJ)
- …new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific ... cycle of clinical development, including study design, initiation, execution,- monitoring , analysis, regulatory reporting, publication, and presentation at national… more
- Merck & Co. (Rahway, NJ)
- …role will develop a plan to-utilize-data visualization, data analysis, data monitoring and data modeling-to enable better business decisions.-Through analysis of ... data collection systems and other strategies that-optimize-statistical efficiency and quality .Develop and-maintain-Site Facility Energy Regression models.Work with Operations and… more
- Twist BioScience (South San Francisco, CA)
- …cloud-based or on-prem environments.Collaborate with DevOps teams to maintain monitoring , logging, and alerting systems for pipeline reliability and ... and storage solutions.Background in assay development, genomics-based diagnostics, or quality control for high-throughput NGS data.Software Development & DevOps… more
- Eisai, Inc (Indianapolis, IN)
- …representatives selling efforts in accordance with strategic plans and compliance, monitoring and driving sales goals, and coaching Sales Representatives on critical ... local and national, health care issues/strategies, customer issues/trends, pathway and quality trends, and best practices to establish credibility beyond product and… more
- Merck & Co. (Rahway, NJ)
- …the lead clinical scientist on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical data/medical protocol deviations in ... Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of trial conduct. Providing… more
- Eisai, Inc (Nutley, NJ)
- …internal reviews, reconciliation and study file archivalPerforms detailed eTMF CRO quality check reviews with follow-up for missing documentation under the ... 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
