- Merck & Co. (North Wales, PA)
- …as determined by senior leadership by providing overall operational support for research conducted in compliance with Good Pharmacoepidemiology Practice (GPP), ... ensure timely management and execution of activities.May participate in internal process improvement initiatives with Research Management and mentoring of other … more
- Novo Nordisk Inc. (WA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …and effectively, and within budget.Regulatory Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to include the ... OverviewAs an integral part of the Lovelace Leadership Team, the Chief Academic Research Officer (CARO) will develop and lead the all of the Institute's Academic … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and metrics. Support continuous process improvement , interpretation of regulations, quality and compliance with regulations and company standards, policies ... and metrics. Support continuous process improvement , interpretation of regulations, quality and compliance with regulations and company standards, policies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mitigated in collaboration with the business functions. Identify appropriate continuous improvement initiatives for quality and compliance related ... improvement to stakeholders via the QMS scheme (ie, Quality Management Review, Quality Review Board) across...that all functions consistently operate in a state of compliance .Facilitate the implementation of the quality strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for established metrics and identifying potential new metricsSupporting continuous improvement projects assigned potentially within regulatory compliance , ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training… more
- Insmed Incorporated (Bridgewater, NJ)
- …York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director, Quality Operations will ... of compliance requirements, work with critical suppliers to ensure quality , consistent supply.Review and monitor all lab processes to ensure they follow… more
- Merck & Co. (Durham, NC)
- …a Right First Time culture by reducing waste and constantly driving continuous improvement . -Responsible to review and approve compliance documents, as per ... a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Merck & Co. (Rahway, NJ)
- …to prepare Standard Operating Procedures (SOP) and cGMP documents.Experience with Quality SystemsExperience in supporting compliance investigations and change ... Job DescriptionThe Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDescriptionThe Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated ... development of new technologies/capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning… more
- Merck & Co. (North Wales, PA)
- …functional areas (eg, Clinical Research , Safety Assessment).Supports maintenance (eg, quality compliance and life cycle management) of VID programs.Supports ... including assisting in preparing submissions, protocol review, and conducting research on regulatory guidance's or competitive intelligence.Primary activities include,… more
- Merck & Co. (North Wales, PA)
- …product lifecycle.Key areas of focus include:the assurance of deliverable quality and process compliance ,effective deliverable development utilizing global ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our...graphics) using global and TA standards and according to quality , compliance and timeliness requirements.-Expertise in SAS… more
- Merck & Co. (Rahway, NJ)
- …in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance .Strategic thinking - ability to turn strategy ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our...claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; ... protocol amendments, site staff and location changes and IRB/REB/regulatory approvals to assure quality of the documentation files and compliance with NN SOPs,… more
- Merck & Co. (Durham, NC)
- …procedures to resolve process/equipment issues, minimize downtime, and ensure product quality .- This role actively supports, participates, and embraces an inclusive ... team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required. Primary activities for this position… more
- Merck & Co. (Durham, NC)
- …for our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement , and earn our right to ... management Actively promotes and maintains a culture of excellence, safety first, quality always, mindset by maintaining records, housekeeping, compliance , and… more
- Merck & Co. (Rahway, NJ)
- … compliance investigations and change management. Experience working with Quality systems. Experience working in an environment with an Automation System ... Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position manages ... assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development… more
- Merck & Co. (Durham, NC)
- …strategic process, equipment, and qualification activities while ensuring product quality and optimized maintenance processes, regulatory compliance , employee ... and provide the best-in-class services with the final goal of delivering our high- quality vaccines to the patients around the world with our core principle of… more
- Merck & Co. (Baton Rouge, LA)
- …PERFORMANCE CRITERIA Operational availability rate of equipment and automated lines. Improvement actions implemented: volume and quality .Preventive actions ... DUTIES Carrying out corrective maintenance.Carrying out preventive maintenance.Carrying out improvement maintenance.Duty 1: Carrying out corrective maintenance.Carries out work… more