- Merck & Co. (Durham, NC)
- …support/awareness is given to issues as they arise Develop training material. Working as a subject matter expert ( SME ), provide necessary training for ... a hands-on approach to problem solving. Quality & Safety Compliance : Must be fully aware of requirement specifications from...system maintenance. Serve as a Subject Matter Expert during tours… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionThe USDA Compliance Subject Matter Expert ( SME ) - Associate Director, will report to the Animal Health Global Quality Compliance ... require collaboration with manufacturing sites, contractors, and suppliers.-Primary Responsibilities:Provide Subject Mater Expertise to ensure our company's manufacturing sites… more
- Credence (Mclean, VA)
- …important world-changing Federal challenges. Credence has an immediate need for Cloud Computing Subject Matter Expert to support an exciting opportunity ... utilizing hands-on experience working as a Cloud Computing Subject Matter Expert . The ideal candidate will possess extensive hands-on experience with various… more
- Eisai, Inc (NJ)
- …mitigate risks.Process Management Supports functional strategy execution and risk management initiativesDepartmental Subject Matter Expert ( SME ) and may ... strategies that deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards. This role manages CRO and… more
- Merck & Co. (Durham, NC)
- …needed to ensure the right support/awareness is given to issues as they ariseServe as a Subject Matter Expert ( SME ) during tours to provide area/process ... Day shift 12 hour rotating 2-2-3 shift scheduleQuality & Safety Compliance :Develop and execute engineering change request (ECRs), as necessary.The successful… more
- Merck & Co. (Durham, NC)
- …to ensure the right support/awareness is given to issues as they arise- Serve as an Subject Matter Expert ( SME ) during tours to provide area/process ... overview information to visitors/auditors upon request- - Quality & Safety Compliance - Foster strong safety culture on the team through actions, coaching, and… more
- Merck & Co. (Durham, NC)
- …support as needed. Participate as an individual contributor on site projects as a technical subject matter expert ( SME ) to meet project objectives and ... Integrity, Data Management, Digital Manufacturing, Global Team Collaboration, GMP Compliance , Machine Troubleshooting, Problem Management, Process Automations, Process Failure… more
- Genscript USA Inc. (Piscataway, NJ)
- Job Scope: The Facility Engineer serves as the primary technical subject matter expert ( SME ) for mechanical, electrical, and plumbing (MEP) ... are designed, constructed, and commissioned to meet performance, safety, and compliance requirements. In addition to capital project responsibilities, the Facility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director can be an extension to the Asset Lead when needed and serve as an SME ( Subject Matter Expert ) on applicable Study Managment processes. He/she ... of the CRO is being completed on their respective studies to ensure compliance with Daiichi Sankyo's quality measures. Analyze CRO performance trends within a… more
- Genmab (NJ)
- …of external data collection standards, and providing SDTM mapping guidance Serves as a subject matter expert on all aspects of standards development that ... need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that...integrity Directly supports knowledge development of others as a subject matter expert on data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter expert in cross-functional teams or committees ... global and regional level as required.Support audit and inspection readiness activities as a subject matter expert . This individual will be accountable for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …trainings within CAR-T manufacturing facility inside of cleanroom environments.Serve as subject matter expert for Learning Management Systems.Support ... CAR-T cGMP Manufacturing facility.Ensure testing and training is completed in compliance with all applicable procedures, standards and GMP regulations.Support day to… more
- Aequor (Thousand Oaks, CA)
- …and senior stakeholders. Mentor and provide technical guidance to staff; act as a subject matter expert for GCR operations. Perform inventory management ... tasks and team support while managing projects in a fast-paced setting. Ensure compliance with safety, quality and data integrity expectations. What we expect of you… more
- Merck & Co. (Durham, NC)
- …ensure the right support/awareness is given to issues as they arise.Serve as a Subject Matter Expert during tours to provide area/process overview ... information to visitors/auditors upon request.Quality & Safety Compliance :Foster strong safety culture on the team through actions, coaching, and… more
- Insmed Incorporated (NJ)
- …deliverables.Communicate and counsel Insmed senior leadership on HEOR strategic priorities.Collaborate as a subject matter expert on HEOR and a strategic ... business needs.Engage with external partners (regulators, HTAs, payers, providers, patients) as a subject matter expert on Insmed's HEOR evidence generation… more
- Merck & Co. (Rahway, NJ)
- …knowledge of country-specific regulations related to trademark development to become a subject matter expert .Educates colleagues on the trademark development ... communication skills. Proficient presentation skills.Demonstrates high learning agility in new subject areas.Preferred Experience and Skills:A minimum of 2 years of… more
- Repligen (Waltham, MA)
- …partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in ... & ITGC ComplianceWe are seeking an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness of internal controls… more
- Syner-G BioPharma Group (Boston, MA)
- …execute, and manage capital improvement projects, renovations, and infrastructure upgrades.Serve as subject matter expert in cleanroom design, building ... expertise to streamline operations, enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and deliver impactful… more
- Insmed Incorporated (NJ)
- …is beneficial (3 years).Deep expertise in adult learning methodologies and training development required. Subject matter expert in training field and ability ... and Field Medical Excellence. The Director, Global Medical Training Strategy will have subject matter expertise in training and deep understanding of assigned… more
- Insmed Incorporated (NJ)
- …working independently with minimal supervision.What You'll Do: Significant scientific contributor and subject matter expert in preparation of clinical ... Regulatory Submissions, and responses to regulatory authorities. As a content expert , this individual has a significant understanding of regulatory requirements and… more
