- Insmed Incorporated (San Diego, CA)
- …and client audit readiness plans. Serve as subject matter expert for stability and sample management related topics.Establish and publish Key Performance ... of areas of responsibility.Participate in daily and weekly operation meetings and Quality Management Reviews.Own and support stability and sample management… more
- Insmed Incorporated (San Diego, CA)
- … expert QA review, collaboration, and direction for laboratory investigations.Apply Quality Risk Management for key processes and systems. Identify ... the overall effectiveness of the Quality department.Assist in other quality assurance related activities as agreed with management .Job Requirements:Minimum… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are achieved on time and budget. Functional Expertise:Serves as a Data Management expert regionally/globally.Acts as coach/mentor at the department level and ... regional Data Management expert .Collaborates cross-functionally during interactions with Regulatory...etc.)Able to lead program and initiative teams to achieve high- quality , on-time deliverablesEffective management and development of… more
- AAOS (Rosemont, IL)
- …contribute to its reach and growth. Quality Program Management Acts as a subject matter expert and partner liaison for registry quality programs ... You are enthusiastic about driving quality improvement in healthcare and making a tangible...meetings and in leading orthopaedic publications. Acts as a subject matter expert related to… more
- Aequor (Bothell, WA)
- …for computerized systems used in GxP operations Support health authority inspections as a subject matter expert ( SME ) for routine CSV lifecycle ... change IT operational events (ie ServiceNow). Knowledge and exposure to Business Quality Management Systems (ie Veeva). Strong technical and problem-solving… more
- Merck & Co. (Durham, NC)
- …meet those demandsReview and approve Change controls, Quality Risk ManagementServe as the Subject Matter Expert for all technical support quality ... the following:Lead the team and others by providing direction and guidanceDeviation management , Review and approve Quality Notifications (QNs)Author, review, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical/Medical Information, Regulatory, and Marketing Management of all system users/participants Subject Matter Expert ( SME ) for annual Corporate ... in the planning, submission, review and approval, distribution and lifecycle management of promotional marketing materials. The Manager will oversee the process… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Duties and Responsibilities: Provides direct leadership to HEPA certification technicians Acts as Subject Matter Expert ( SME ) for HEPA certification ... Strong instrumentation and HEPA certification experience Proficient use of Asset Management and Quality Systems Strong understanding of industrial… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the routing and approval flow in Document Change Control (DCCs) Reviews local Quality Management System (QMS) documents to ensure clear & reader friendly ... Process Tracks, GMP partners & Training partners on site. Expert in local change control process to support revision...documents Supports the document processing in collaboration with NNUSBPI SME 's & process groups Develops & maintains internal &… 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 ... that provides a high degree of technical and project management responsibility. The Specialist -Engineering position will report to...to enable lab startup. They will also become a subject matter expert for a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …includes Customer Care, Patient Support Hubs, and Patient Assistance Programs Serve as the Subject Matter Expert ( SME ) across diverse functional areas, ... requirements, user acceptance testing and supporting toolsets Understanding of product management principles and agile best practices and quality improvement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Manager(s) with communication of safety information to others Process & Documentation: Serves as subject matter expert ( SME ) on Safety database systems ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Identify areas for improvement with input from functional area Subject Matter Experts and make recommendations for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and provide coordination to ensure timely and compliant implementation of process improvements.Serves as Subject Matter Expert ( SME ) in preparation for ... team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and… more
- University of Maryland Medical System (Glen Burnie, MD)
- …Degree Practice Focus Areas: . Member of professional organization . Serves as super-user or subject matter expert ( SME ) . Participates in organizational ... University of Maryland Baltimore Washington Medical Center (UMBWMC) provides the highest quality health care services to the communities we serve. Our medical center… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and conditions as well as pricing for optimal leverage and synergies- Act as the Subject Matter Expert for Strategic Sourcing's e-Procurement suite of tools ... Global) for given commodities/business areas and leading the overall supplier relationship management program for DSI, for DS products and alliances. Cultivates a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and competency of the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....areas of opportunity aligned with Therapeutic Area priorities Utilizes subject matter expertise and analytical tools to… more
- Merck & Co. (Durham, NC)
- …ability to train others.Works independently, Trains others, and ability to trouble shoot, Subject Matter Expert in automated systems (SAP, MES, ... and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required.Performs housekeeping in all work areas. Executes… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a team based on an assigned production shift schedule.Key Responsibilities Serve as a subject matter expert for warehouse operations and perform daily ... processes, including inbound, outbound, storage, and replenishment.Work with inventory management systems and execute cycle count and reconciliation activities to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …warehouse activities as needed.Key Responsibilities Serves as a subject matter expert for inventory management and warehouse operations/logistics. ... Specialist will be part of the Technical Operations team responsible for inventory management in support of production of a personalized cell therapy to support both… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …substituted for the supervisorial requirements.Additional duties may include acting as an internal subject matter expert and limited scope client interaction ... or resolution of study issues. The Laboratory Supervisor may review, perform quality control correct and give guidance to director reports. The laboratory supervisor… more
