- Merck & Co. (Rahway, NJ)
- …of patients and global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides ... oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical… more
- BioAgilytix (Durham, NC)
- …building a high-performing data management team, identifying roles in data engineering, quality , and automation as the function matures.Sponsor Data ... a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with… more
- Merck & Co. (Rahway, NJ)
- …Perform independent quality review and approval of batch records, testing data , and related documents required to release or reject product. Make independent ... metrics by summarizing findings during documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support… more
- Novo Nordisk Inc. (Durham, NC)
- …efforts. Identify and share better practices, to include increasing awareness of data management standards & validation to create improvements in methods, ... areas Own self development & initiative to understand the site process control systems, data management systems, and differing data sources (PCS, MES, SAP,… more
- Merck & Co. (Rahway, NJ)
- …principal component analysis, etc.Develop and implement statistical process control methodologies and data anlaysis to ensure the quality and reliability of ... Job DescriptionThe Principal Scientist, Process Control and Data Analytics will be responsible for leading a team focused on developing and implementing product… more
- Merck & Co. (South San Francisco, CA)
- …leads the assessment of drug candidates. The successful candidate will join a dynamic Data Science team focused on bringing AI/ML approaches to bear to improve the ... speed and quality of decision-making in drug discovery and development. PDMB...of GenAI solutions with PDMB's scientific processes. -Work with data engineers and architects in IT to build a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and customer focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...Quality Department as needed and assigned by NAO Quality Management Attend relevant symposia, conferences and… more
- Repligen (Waltham, MA)
- … quality assurance. Proven experience with ISO 9001 audits and supplier quality management . Strong problem-solving skills, including root cause analysis and ... Monitoring and ReportingCollect, analyze, and report on monthly supplier performance data , including quality , delivery, and service metrics.Prepare and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and NAO Quality Department as needed and assigned by NAO Quality Management Attend relevant symposia, conferences and scientific meetings, as necessary ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...within the organization and function within the role of Quality Business Partner where requested by management … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experienced quality representatives and/or contingency workers. Essential Functions Deviation Management Develops and serves as Quality Point of Contact for ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Aequor (Thousand Oaks, CA)
- …Agar plates. Working in a laminar flow hood. Work with Laboratory Information Management System (LIMS) and/ or SmartLab (LMES) with efficiency and accuracy. Job ... This position is a unique opportunity to work within Quality Control at the Thousand Oaks site and to...against SOPs and enter results in a laboratory information management system (LIMS) and/ or SmartLab (LMES). This position… more
- Formation Bio (New York, NY)
- …to ingest and transform unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power discovery and ... compute strategy, access control, and CI/CD pipelines. Establish standards for data governance, observability, and metadata management . Ingestion & … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with strategic alignment.Effective in fast-paced environments with a focus on quality and documentation.Skilled in change management and guiding teams ... safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness… more
- Aequor (Houston, TX)
- …deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to prevent recurrence. ... from both internal and external clients on the compiled final report. Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA)… more
- Aequor (West Greenwich, RI)
- …be responsible for activities including microbiology & analytical testing, sample and data management and equipment and instrumentation operation and maintenance ... operations and Environmental/Water monitoring. 2. Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures.… more
- Aequor (Thousand Oaks, CA)
- …hours The ideal candidate will have a strong attention to detail, effective time management , and clear communication skills. They should have at least a high school ... sampling and inspection of raw materials and components and for performing Quality review of documentation for assigned functions (eg equipment and maintenance… more
- Eisai, Inc (Nutley, NJ)
- …(CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice ... preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ years...carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for… more
- Merck & Co. (Boston, MA)
- …to collaborate across departments to ensure awareness and access to high- quality information that drives scientific discovery and innovation.- The ideal candidate ... Familiarity with GenAI is a plus.-In addition, the candidate will leverage data to drive resource utilization and maintain up-to-date awareness of literature-related… more
- Aequor (Cincinnati, OH)
- …commercial, validation and stability samples in accordance to written methodology Analyze data against approved specifications, notifying management of any OOS ... Quality Control Analyst I Does the position allow...on daily/weekly/monthly objectives Shares information with others - keeping management informed and helping department to meet the goals… more
