- Merck & Co. (North Wales, PA)
- …Intelligence (AI), Artificial Intelligence Strategy, Building Partnerships, Customer Relationship Management (CRM), Electronic Health Records (EHR), ... maintaining strategic alliances.Experience identifying and evaluating new partners in the electronic health records (EHR) industry, health care institutions and… more
- Aequor (Athens, GA)
- …Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy systems. Electronic ... 11, GLP (FDA and EPA), GMP (FDA and EU), VICH Internal BI policies on Records Management , Training Management , Information Protection. The individual must be… more
- Merck & Co. (Rahway, NJ)
- …and regulatory filings. Perform independent quality review and approval of batch records , testing data, and related documents required to release or reject product. ... complex document types, as required, including deviations, investigations, change records , analytical method validations, method transfers, analytical methods, specifications,… more
- Merck & Co. (Rahway, NJ)
- …Clinical Trials, Coaching, Communication, Computer Science, Data Analysis, Data Management , Data Modeling, Electronic Submissions, Microsoft Project, Numerical ... health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality management … more
- Twist BioScience (South San Francisco, CA)
- …IQ, OQ, PQ protocols and documentation, specifically tailored for custom software. Electronic Batch Record (EBR) Management : Lead the design, development, ... and continuous improvement of electronic batch records within the MES, ensuring...the MES, ensuring accurate capture of manufacturing data, deviation management , and electronic signatures.Vendor & Internal Resource… more
- Merck & Co. (Durham, NC)
- …PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach ... and power tools, instruments and testing apparatus common to the electronic , mechanical, and instrumentation fieldsAbility to read P&ID's, electrical drawings,… more
- Merck & Co. (Durham, NC)
- …PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach ... and power tools, instruments and testing apparatus common to the electronic , mechanical, and instrumentation fieldsAbility to read P&ID's, electrical drawings,… more
- Merck & Co. (Rahway, NJ)
- …Partner Groups such as GES (Global Engineering Services), Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors.Provide engineering ... Facilitate equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with site & global engineering… more
- Merck & Co. (Durham, NC)
- …and specification data within the computerized calibration and maintenance management system.Troubleshoots equipment and performs necessary repairs. Utilizes various ... lifting of up to 30 pounds.Perform other tasks as requested by site management to meet the requirements and goals of the VMF Integrated Process Team.Perform… more
- Repligen (Hopkinton, IA)
- …is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting the document control department ... in a timely manner to meet established deadlines (paper and electronic ).Maintains related database systems, if applicable, logs and complete forms/ records… more
- Merck & Co. (North Wales, PA)
- …deliverables for R&D projects (data, analyses, tables, graphics, listings)Strong project management skills; leadership at a program level; determines approach and ... experience at the leadership level including the development of electronic submission deliverables.Designs and develops complex programming algorithms.Ability to… more
- Merck & Co. (Rahway, NJ)
- …performance in a dynamic environment, leaning into areas of talent management and succession planning, operational efficiency and compliance, and external ... and increase effectiveness by enabling clear, concise communication directly to senior management at our Company.Partners with members of GRACS Leadership Team to… more
- Merck & Co. (Upper Gwynedd, PA)
- …acceptability and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for ... communicate and escalate potential regulatory issues to GRACS CMC management , as neededDemonstrate an understanding of regulatory affairs and apply… more
- Aequor (North Creek, WA)
- …in lab notebooks and technical reports Meticulous maintenance of laboratory records /notebooks, equipment logbooks, and other electronic files Collaborating with ... skills, and a willingness to learn. Principal Responsibilities: Laboratory management (maintaining and cleaning equipment, analytical instrument maintenance, ordering… more
- Aequor (Hicksville, OH)
- …component number. Reviews batch paperwork for accuracy and issues to the batch records clerk. Checks and prepares paperwork for upcoming batches. Sets up and ... to Stock (RTS) or paper transfer using scanning guns. Sets up electronic marquees indicating the product information for production lines. May calibrate… more
- Merck & Co. (North Wales, PA)
- …understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards Experience ensuring ... vaccine regulatory application submission experience including the development of electronic submission deliverables Experience assuring programming consistency across protocols… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems across the organization. This position ensures that all global systems, electronic records , validation processes, and regulated applications meet strict ... experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong expertise in GxP regulations,… more
- LogixHealth (Bedford, MA)
- …become the nation's leading provider of unsurpassed software-enabled revenue cycle management services, offering a complete range of solutions, including coding and ... claims management and the latest business intelligence reporting dashboards for clients in 40 states. Since our first day, we have had a clear vision of a better… more
- Leidos (Bethesda, MD)
- …reorder and clean their Shared Drive and support the implementation of a customer electronic records management system (ERMS). + Identify, document, and ... **Leidos** has a new and exciting opportunity for a ** Records Management Analyst** in our **National Security... from creation to disposition for both paper and electronic records . Evaluate and institute customer RCSs… more
- NANA Regional Corporation (Ashburn, VA)
- …and constraints and provide recommendations as to the Government's preparation for electronic records management . Develop strategy, processes, and procedures ... of electronic records to support implementation of electronic Records Management Application (RMA). **Responsibilities** + Develop records … more
