- Merck & Co. (Millsboro, DE)
- Job DescriptionThe Senior Quality Specialist ensures product/ process quality system adherence and batch record review, completes quality checks and SAP ... within a team environment. Primary Responsibilities - Provides direct Quality support for Integrated Process Team (IPT) or Center of Excellence (COE) to which… more
- Merck & Co. (Durham, NC)
- … Assurance (QA), Quality Control Management, Quality Improvement Programs, Quality Operations, Quality Process Development, Quality Standards, ... to problem solving, and be self-motivated to identify and initiate process improvementprojects.The Quality Assurance Specialist provides support to vaccine,… more
- Aequor (Thousand Oaks, CA)
- …regulations Manages and provides oversight of documents / records within the Quality Management System Oversight of process key performance indicators and ... journals, technical procedures, or governmental regulations Experience with risk-based Supplier Quality Management process . Management of Global Inspection and… more
- Formation Bio (New York, NY)
- …internal and external teams to implement corrective and preventive actions. Lead the quality review process , ensuring the effective review and approval of batch ... the PositionWe are seeking a highly accomplished, strategic Vice President of Quality Assurance. In this pivotal role, you will have the opportunity to… more
- Insmed Incorporated (NJ)
- …patient safety and product quality . The position requires proficiencies in key Quality Systems Process such as Change Control, Deviation, CAPA, Supplier ... Quality , Internal/External Audit, Quality Complaints and Production Process Control.What You'll Do: Provide Quality Assurance oversight for GxP… more
- Merck & Co. (Durham, NC)
- …approach to problem solving, and be self-motivated to identify and lead process improvement projects.The Quality Assurance Specialist provides support to ... Monitoring, GMP Compliance, IS Audit, Multidisciplinary Collaboration, Problem Solving, Process Improvement Projects, Process Simulation, Quality … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …authority regulations and Novo Nordisk requirements in relation to the Pharmacovigilance (PV) process at NNI. This role fulfills the Quality Assurance function ... workers. Essential Functions Deviation Management Acts in role of Quality Assurance for NN Deviation process within...role of Quality Assurance for NN Deviation process within the PV domain, including review and disposition… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study teams in a timely manner.Provides oversight for external data validation and quality control process for verification of the data structures in line ... portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs.Partner with Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution ... Quality at all stages of the program management process .May Interact with management at all levels and external...such as Quarterly Quality Reports (QQRs) and Quality Review Boards (QRBs).Collaborate with business process … more
- Merck & Co. (Rahway, NJ)
- …reduce costs, minimize experimental batches, shorten timelines, and improve product quality and process robustness. Communicate complex modeling insights clearly ... Job DescriptionThe Process Excellence Team is seeking a Senior Scientist who will lead Process and Product Modeling efforts across the Global Animal Health… more
- Repligen (Clifton Park, NY)
- …maintain compliance with Good Manufacturing Practices (GMP).Identify and report any quality or process deviations to supervision.Support continuous improvement ... components, and tubing according to work instructions, batch records, and quality standards.Perform inspection of components for defects, damage, or contamination… more
- Insmed Incorporated (NJ)
- …Development QA activities.Support investigations and root cause analysis of product or process issues related to clinical manufacturing.Drive Quality input into ... phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external partners. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for essential tasks at all times Provides strategic input and contributes to process / quality improvement initiatives Guides the successful completion of major ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....alliance management preferred Novo Nordisk is currently in the process of adjusting job titles globally. Please note that… more
- Merck & Co. (Rahway, NJ)
- …in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ability to turn strategy ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Jazz Pharmaceuticals (San Jose, CA)
- …improve and simplify processes (via BPO network) and introduce best practices for quality and compliance and identifies process gaps and facilitates resolutions ... leadership for global PV and REMS to execute the quality framework of controls and oversight necessary to achieve...improve after any compliance incident. Collaborate with GRADS Compliance Process and Training to design a strategy to pre-empt… more
- Merck & Co. (North Wales, PA)
- …ADRG also required.Must possess demonstrated success in the assurance of deliverable quality and process compliance.Excellence in technical writing and ability ... Job Description Responsibilities: Provide oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions… more
- AUROBINDO (Durham, NC)
- …finished product release goals. Be able to perform all IPQA (In- Process Quality Assurance) functions during IPQA absences.ResponsibilitiesCoordinate production ... to meet finished product release goals.Be able to perform all IPQA (In- Process Quality Assurance) functions during IPQA absences.Must be able to read, write and… more
- Merck & Co. (Rahway, NJ)
- …Compliance, Immunochemistry, Industrial Hygiene, Innovation, Inventory Management, Management Process , Manufacturing Quality Control, People Management, ... Pilot Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal… more
- Merck & Co. (North Wales, PA)
- …Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting ... that project plans are executed efficiently with timely and high quality deliverables.-For assigned projects the position serves as the statistical programming… more
- Merck & Co. (North Wales, PA)
- …the entire product lifecycle for the assigned projects. Assure deliverable quality and process compliance.Responsible for effective deliverable development ... CDISC and ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also required.Must possess broad knowledge and… more
