- Merck & Co. (Durham, NC)
- …Documentation Management .-Ensure compliance with all global and regulatory standards.Serve as the Subject Matter Expert ( SME ) for areas of ... certification. Significant experience in biologics, vaccines, and/or biopharmaceuticals compliance. Experience as Subject Matter Expert ( SME ) in… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to make improvement to existing systems as needed. This role is the site Subject Matter Expert ( SME ) for site GMP Clean Utilities infrastructure ... will include:Strong technical skills, be the Subject Matter Expert ( SME ) from equipment Utilities-HVAC systems . Deep technical expertise… more
- Merck & Co. (Durham, NC)
- …sponsor for the problem-solving efforts and solutions offered by other shifts and teams Subject Matter expert for LOTO and permit writing for maintenance ... activities, Safety Management Information Systems (SMIS) transactions Knowledge of...given to issues as they arise Serve as a Subject Matter Expert during tours… more
- Merck & Co. (Rahway, NJ)
- …of clinical supply chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise. - ... - Preferred Experience and Skills: - - Proficiency in using supply chain management systems and software, including experience with ERP systems (eg, SAP),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …path analyses and support scenario planning.Maintains project status in the project management information systems . Prepares scope change proposals and stage ... immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic… more
- Merck & Co. (Rahway, NJ)
- …activities in support of clinical supply planning group (eg, process improvement initiatives, subject matter expert roles, cross functional projects, etc.) - ... supply planning function. - Proficiency in using supply chain management systems and software, including experience with...execute on collaborative projects and develop subject matter expertise - Knowledge of order management ,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with project objectives Act as system administrator for the BMS system and act as subject matter expert regarding technical issues Support and develop and ... Associate's degree with seven (7) years' experience in Automation, Building Management Systems , Design and construction required Bachelor's Degree with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …gather, document, implement and validate all system requirements for associated module(s).Serve as the Subject Matter Expert ( SME ) for respective modules ... end-user experience.Responsibilities- HR Systems ManagementAct as the principal functional expert and advisor for implementation and ongoing management and… more
- Novo Nordisk Inc. (Durham, NC)
- …Nordisk procedures & FDA 21 CFR Part 11 requirements Support audits & inspections as SME for QC lab computer systems Coach & train colleagues & stakeholders in ... Knowledgeable in the following systems : Windows operating systems , Active Directory User, Groups & Computer Management... systems , Active Directory User, Groups & Computer Management , Empower, LIMS, MS SQL preferred Proven expertise, (eg… more
- Merck & Co. (Durham, NC)
- …recurrence including the development and implementation of corrective actions. Over time, become a subject matter expert ( SME ) in specific process steps, ... automation technology platforms, and specific systems . Over time, becomes expert practitioner of...of structured problem solving and after-action reviews. Supports knowledge management and team learning to improve support of manufacturing… more
- Merck & Co. (Durham, NC)
- …uptime, minimizing cost and maintaining process consistency.Develop training material. Working as a subject matter expert ( SME ), provide necessary ... and/or calibration and/or maintenance background-Strong planning, scheduling, and time management skillsWorking knowledge of regulatory requirements in accordance with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …testing and release of product to patients in a cGXP environment.Key Responsibilities Acts as a subject matter expert ( SME ) for 21 CFR Parts 210, 211, ... remediation and improvement efforts within the plant of all computerized systems .Conducts site-specific computerized system data management monitoring including… more
- Merck & Co. (Rahway, NJ)
- …molecule, macrocyclic peptides, bioconjugates) drug substance lab and the Specialist will become a subject matter expert for this lab, and also for the ... a fast-paced job that provides a high degree of technical and project management responsibility. The Specialist -Prep Lab Engineering position will report to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(drug/establishment listings) and submission to FDA databases. This individual acts as the Subject Mater Expert ( SME ) for electronic reports that are ... accessible Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.) Works directly with Regulatory Project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …audits.Supports Quality risk assessment teams.Review/approve documents as a Quality on the Floor Subject Matter Expert ( SME ).Remain current in skills ... GMP decisions.Independently resolves problems through the use of quality systems .Develop improvement ideas and independently implement associated solutions.Support QPIP… more
- Twist BioScience (South San Francisco, CA)
- …closely with Internal Audit.Key Responsibilities:Act as a hands-on leader and SOX compliance subject matter expert who works with cross-functional process ... of SOX compliance professionals, including analysts, third-party service providers, and subject matter experts Provide strategic thinking, thought leadership,… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …laboratory equipment and supplies. Additional duties may include acting as an internal subject matter expert and limited scope client interaction to ... Microsoft Office, as well as the ability to learn department-specific computer systems as needed. Physical RequirementsWork is performed in a wet laboratory… more
- Merck & Co. (Rahway, NJ)
- …with a strong, integrated understanding of the strategic elements of drug development. As a subject matter expert , the Director within the QP2-IO Group will ... decisions of drug development teams. Primary Responsibilities: Serving as an expert representative for QP2 -IO on Oncology development teams.Framing critical… more
- Novo Nordisk Inc. (Durham, NC)
- …to the automation-related specifications & maintenance plans Support audits & inspections as SME for process control systems Coach & train colleagues & ... make what matters. The Position Improve reliability of the process control systems to meet current & projected customer, business & regulatory requirements through… more
- Novo Nordisk Inc. (Durham, NC)
- …plans Own self development & initiative to understand the site process control systems Support audits & inspections as SME for specified process applications ... of identified local manufacturing applications. Improve reliability of process control systems to meet current & projected customer, business & regulatory… more
