- BioAgilytix (Durham, NC)
- …and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, ... sharing between systems, with a focus on operational efficiency and data integrity . Data Quality & Compliance Automation: Use Robotic Process Automation… more
- Merck & Co. (Rahway, NJ)
- …integrity principlesCoach and mentor staff on analytical techniques, problem solving, and data integrity as needed.Share best practices across the company to ... mindset.Exhibit exceptional leadership abilities and strong knowledge of cGMP and Data Integrity .Uphold strong values essential to fostering and contributing… more
- Twist BioScience (South San Francisco, CA)
- …biomanufacturing operations. This critical role will drive efficiency, quality, and robust data integrity within a highly automated environment. The effective ... QMS), and ensure compliant data flow across the biomanufacturing ecosystem. Data Integrity & Reporting: Architect and ensure the accuracy, integrity ,… more
- Insmed Incorporated (San Diego, CA)
- …is necessary, as is knowledge of regulatory guidelines like cGMP and ICH, and data integrity principles such as ALCOA. Strong data analysis, problem-solving, ... Guided by our core values of collaboration, accountability, passion, respect, and integrity , we aim to foster an inclusive, diverse, and flexible work environment,… more
- Aequor (Vacaville, CA)
- …3250, and Endress&plusHauser Raman. They should also have a strong understanding of data integrity principles and experience using data management systems ... of bio-tech related analytical methods and practices Experience with analytical systems, data analysis, and troubleshooting Knowledge of SAP system is a plus Must… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and compliance related activities for US Talent Acquisition. Responsible for oversight of master data and data integrity related to US Talent Acquisition. ... firms and HR associations. Essential Functions Develop, deliver and continually improve data representation and delivery applications (including data quality) in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …utilities, and facility qualification, process validation, shipping validation, and data integrity .Key Responsibilities Provide quality and compliance oversight ... process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity , and maintenance activities within the siteReview… more
- Aequor (Thousand Oaks, CA)
- …as CDOCS (Veeva Vault), LIMS and/or SmartLab (LMES). Experience and knowledge of Data Integrity Requirements in QC systems. Proficient in Microsoft Office (ie, ... internal and external inspections and audits as needed (lab preparation, data retrieval etc.). Troubleshoot, solve problems, and communicate with relevant team… more
- Insmed Incorporated (San Diego, CA)
- …observations and development of adverse trends) to ensure patient safety and data integrity .Supports strategic direction with cross functional working groups to ... Guided by our core values of collaboration, accountability, passion, respect, and integrity , we aim to foster an inclusive, diverse, and flexible work environment,… more
- Formation Bio (New York, NY)
- …critical periods. Leverage AI-driven tools and automation to improve efficiency, data integrity , and decision-making processes. Communication & Cross-Functional ... planning for major program decisions. Synthesize technical, financial, and operational data to drive decision-making. Manage ambiguity by proactively identifying … more
- BioAgilytix (San Diego, CA)
- …and revision of Computer System Validation procedures and policies (validations, change control, data integrity ), following 21 CFR Part 11, Annex 11, GxP, and ... incident handlingAdditional ResponsibilitiesAt all times, protect the security and integrity of company systems Other duties as assignedMinimum Preferred… more
- Formation Bio (New York, NY)
- …and support other balance sheet reconciliations Prepare and book accruals and help maintain data integrity across our P&L Track and maintain fixed assets and ... support month-end close activities Help ensure accuracy and completeness of financial data in NetSuite and FloQast Support ad hoc projects and automation initiatives… more
- Eisai, Inc (Nutley, NJ)
- …capabilities to independently carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong ... (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ years of experience in GCP auditing.… more
- Merck & Co. (Rahway, NJ)
- …drafting clinical study protocols to overseeing protocol adherence to assessing patient-level data , ensuring data completeness and integrity , and ultimately ... Testing, Clinical Trial Planning, Clinical Trial Support, Cross-Functional Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise in GxP regulations, CSV, 21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system architecture, cloud solutions, ... integrations, and cybersecurity in regulated environments - Preferred Strong strategic thinking, decision-making, and leadership skills - Preferred In-depth knowledge of GxP application solutions and regulatory complianceProven ability to manage and deliver… more
- Merck & Co. (North Wales, PA)
- …collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data -to ensure quality and integrity of trial conduct. ... medical monitoring team in review and interpretation -of clinical data /medical protocol deviations in collaborations with the Clinical Director.Other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technological and data innovation, maintaining our facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will ... role reports directly to the Vice President of Enterprise Data & Advanced Analytics (ED&AA) and serves as a...The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians, and is… more
- Merck & Co. (North Wales, PA)
- …collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of ... medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaborations with the Clinical Director.Other responsibilities… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …with cross-functional teams. Influence research methodologies, experimental design and data analysis approaches.Market Trends & Innovation: Stay abreast of industry ... while exceeding targets, and the ability to leverage technology and data to enhance operational efficiency and decision making.Must have excellent organizational… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Update data in planning systems such as SAP, OMP, and RTMSto ensure integrity Assist with updating SAP Material Master Data , including BoMs, master recipes, ... OMP and shop floor planning project teams on master data and system adoption Analyze and apply resolutions for...integrity Create reports and automation models using available data Ensure effective communication with both internal and external… more
