- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(DM) Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external ... by clinical study teams in a timely manner. Provides oversight for external data validation and quality control process for verification of the data … more
- BioAgilytix (Durham, NC)
- …UiPath or Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data ... with RPA platforms (eg, UiPath, Microsoft Power Automate) to independently automate data validation checks and routine compliance tasks.Skilled in developing and… more
- Merck & Co. (Rahway, NJ)
- …and preventative actions.Directly contributes to experimental design, execution, and data interpretation for validation studies.Support internal and external ... be able to provide subject matter expertise for CCIT technologies, method development, validation , and method transfer, as well as provide technical and GMP support… more
- Aequor (Buffalo, NY)
- …with cross-functional teams. Key Accountabilties: Analyze capital project work Perform data validation Enforce controls policies Partner cross-functionally with ... financial health of the organization. This involves analyzing financial data , preparing insightful reports, and developing recommendations to enhance profitability… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …include validation protocol execution (IQ, OQ, PQ & PV), data analysis and final report preparation for utilities, equipment and instrumentation Maintain ... The Position The person in this role will also be responsible for validation activities in several areas of pharmaceutical manufacturing including, but not limited… more
- Aequor (Swiftwater, MN)
- …processes including cGMP's in a pharmaceutical environment - Experience in system testing, validation , and master data management - Familiar with 21CFR part 11 ... LIMS system. Maintenance support will include supporting Business Administrators in, updating master data for new and existing products, updating master data for… more
- Aldevron (Miami, FL)
- …for vital new discoveries worldwide. You will be a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation . ... You will assist in representing the Analytical Method Validation team in matters related to analytical test method validation and test method transfer.… more
- Raytheon (Andover, MA)
- …test fixtures and equipment to ensure accurate and reliable testing.Analyze test data to identify trends and root causes of failures, and implement corrective ... actions to improve product quality and yield. Collaborate with design, process, and manufacturing engineers to optimize SAW filter performance and manufacturability.Ensure compliance with industry standards and internal quality management systems.Provide… more
- Eisai, Inc (Bethesda, OH)
- …workflows. Data Quality & Consistency: Proficient in establishing and enforcing validation rules to ensure data integrity, consistency, and high-quality ... your profile, we want to hear from you. The Data Operations Group at Eisai, Inc. is looking for...at Eisai, Inc. is looking for an Director - Data Scientist/Programmer to drive drug development through predictive modeling… more
- Merck & Co. (Sacramento, CA)
- …and change control processes.Ability to analyze, interpret, and troubleshoot analytical data .Experience in method transfer, method validation , new product ... robustness of external /testing through implementation of proactive tools, assay data trending, corrective actions and best practices.Identify and resolve analytical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … data management practices. The position also involves risk-based validation of IT services and determining audit targets for GxP ... research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director, Data Quality and Integrity (Global R&D & PV QA) ensures high standards of… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Precision Genetics group within the Data , AI and Genome Sciences (DAGS)-Department is recruiting-an Associate Director, Computational ... Biology-in-Cardiometabolic Drug-Discovery- Data Sciences. We are seeking an experienced computational-biologist with a proven track-record in applying human genetics… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Precision Genetics group within Data , AI and Genome Sciences (DAGS). Our department is recruiting a Senior Director, who will serve as the ... Computational Biology lead for Cardiometabolic Drug Discovery Data Science. We are seeking an experienced computational biologist with a proven track-record in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization. This ... position ensures that all global systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements,...21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system… more
- Twist BioScience (South San Francisco, CA)
- …operations. This critical role will drive efficiency, quality, and robust data integrity within a highly automated environment. The effective utilization and ... requirements gathering, system design, coding standards, development, rigorous testing, validation , deployment, and post-go-live support for new and existing… more
- Merck & Co. (Rahway, NJ)
- …post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- Eisai, Inc (Nutley, NJ)
- … Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills with ability to effectively manage and guide ... Clinical Programming manages and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes but… more
- AUROBINDO (Durham, NC)
- …the world a healthier place to live in.Job OverviewReview and approve validation deliverables associated with various Aurolifesystems such as LIMS, Quality Assurance ... and approval of test scripts and defects associated with computersystems validation .Partner with IT to ensure risk assessments, incident management, andOversight is… more
- Aequor (Seattle, WA)
- …therapy products.Familiarity with cell therapy processes and cGMPsExperience assimilating large data sets in support of batch history sections for regulatory ... submissions.Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred. Position SummaryCell Therapy Technical… more
- Eisai, Inc (Exton, PA)
- …suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting ... for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal departments are done correctly and effectively3.… more
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