- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance , Medical ... and the business users to define user information needs.Provide informatics project management , SDLC Quality Model expertise, and computer system validation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance , Medical ... Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management . Develop a strong, positive strategic business… more
- Merck & Co. (Durham, NC)
- …drug substance or drug product.GMP experience with qualification of equipment.Experience with Quality Risk Management .Project Management experience in ... Job DescriptionPosition Description: Specialist, Quality Assurance Our Company will construct...proceed in compliance with cGMP, regulations, and our Company's Quality Management System.Supporting areas such as Design,… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Shop Floor Quality Assurance Associate is responsible for all Quality related functions that directly support Durham within the Vaccine ... while actively participating in and embracing an empowered team culture.-The Shop Floor Quality Assurance Associate is responsible/accountable for Quality … more
- Insmed Incorporated (San Diego, CA)
- …Checks. Provide expert QA review, collaboration, and direction for laboratory investigations.Apply Quality Risk Management for key processes and systems. ... effectiveness of the Quality department.Assist in other quality assurance related activities as agreed with management .Job Requirements:Minimum BS degree… more
- Merck & Co. (Durham, NC)
- …analytical changes and strong partnership with Laboratory Operations, Laboratory Quality Assurance , Divisional Analytical groups, and manufacturing areas ... forum to escalate concerns and best practices Proactively partners with Laboratory Quality Assurance personnel to ensure compliance with regulations, guidelines… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …including audits, regulatory intelligence, regulatory inspections, change management , and quality risk management and support strategic changes to ... industry best practices and internal standards as well as managing quality assurance processes and leading continuous improvement initiatives within… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed ... consumables, as well as interact with Production, Technology, and Quality Assurance as required to support vaccine...improvement or learning events, as guided or approved by Quality management Author, review, and approve SOPs… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Quality Assurance (QA) group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and ... working across countries in a multi-cultural environment. Partner with our company IT Risk Management organization and our primary customers / business partners… more
- Merck & Co. (Rahway, NJ)
- …confidence in a changing world.-We provide value-added independent and risk -based audit, assurance and advisory services.Position Responsibilities:The successful ... and testing information technology general controls (ITGCs) to provide reasonable assurance that adequate application and infrastructure internal controls are both… more
- Merck & Co. (Rahway, NJ)
- …a breadth of experience including finance, accounting, analytics, risk management , and special project opportunities.Corporate Audit and Assurance Services ... a deeper knowledge of internal controls, business compliance, and risk management . Individuals will be based in...walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities, timelines and resource requirements for CSV projects. Work within a risk -based framework (Computer Software Assurance (CSA)) that is compliant with ... issues, Good Automated Manufacturing Practices (GAMP5) and Good Practices Guides, Risk -Based Approach/Computer Software Assurance (RBA/CSA) to assure related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to ... requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for… more
- Rose International (Chappaqua, NY)
- … ManagementThe Paralegal-Legal Services Specialist assists the Senior Director Risk Management & Quality Assurance in coordinating the provision of ... comprehensive risk management services at Optum Medical Care, PC for all...Experience Requirements: Bachelor''s degree, Paralegal Certificate, 5+ years of risk management / legal experience Experience with legal… more
- Merck & Co. (North Wales, PA)
- …b) Data Mastering, Data Governance including but not limited to Data Marketplace, Data Quality , Data Risk Management c) Value Realization with use of ... the decision. Operate with Integrity and ensure adherence with organization policies, quality assurance and data protection processes.Conduct innovation proof of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years of professional experience within the pharmaceutical industry working within Quality Assurance is required.Must have a broad understanding of ... systems such as Sharepoint, LMS, Trackwise Digital and other quality management systems.Strong interpersonal, communication, technical writing, negotiation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns and trends ... in support of site improvement projects and strategies.Be a Subject Matter Expert on quality assurance topics within the group in support of QC lab… more
- Aequor (Seattle, WA)
- …and company policies. 2. Deviation Management : Collaborate with laboratory staff, quality assurance , and regulatory affairs teams to document and assess ... environment. Familiarity with regulatory guidelines (eg, CLIA, CAP, ISO) and quality management systems. Excellent written and verbal communication skills;… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …critically review investigations, interpret results and generate technical conclusion consistent with Quality risk management principles.Must be able to ... preferred. A minimum of 5 years of operations or quality Assurance experience within a cGMP environment...manufacturing experience preferredSupport writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed… more
- Merck & Co. (North Wales, PA)
- …to anticipate stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong ... ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical… more
