- BioAgilytix (Boston, MA)
- … with national/international GxPsObtains and maintains professional and technical knowledge by attending educational workshops; reviews professional publications ... to the patients who need them.We're seeking a detail-oriented and proactive Corporate Compliance Specialist to join our team. In this role, you'll play a crucial… more
- Merck & Co. (Durham, NC)
- …and QO Lab documentation, protocols, procedures, calibration and maintenance program documentation, and change management (change requests) activities. Additionally, ... of EMSS, Warehouse, and QO lab documentation (eg, qualification protocols, technical studies, change controls, SOPs, Work Instructions, Job Aids, Preventive… more
- Merck & Co. (North Wales, PA)
- …and compliance robustness and identify Quality risks.- Work with internal colleagues and external partners to remediate risks as appropriate.- Ensure that ... (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current Good Manufacturing Practices (CGMPs), other worldwide regulations… more
- Merck & Co. (Rahway, NJ)
- …in some 150 markets.Accountable for all Environmental, Health, and Safety (EHS) program execution and compliance at our Manufacturing Division's Animal Health ... compliance through active participation and promotion of our Company's EHS&S Program .Assure compliance objectives and team goals are achieved per requirements… more
- Novo Nordisk Inc. (Boulder, CO)
- About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as ... and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado… more
- Merck & Co. (North Wales, PA)
- …areas of focus include:the assurance of deliverable quality and process compliance ,effective deliverable development utilizing global and TA standards that optimize ... graphics) using global and TA standards and according to quality, compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including… more
- Merck & Co. (Durham, NC)
- …equipment including Filling Line, Lyophilizer, Autoclaves, Washers, Incubators, etc.Strong technical and customer service-oriented leader to support the Teknika IPT. ... with optimized product quality and manufacturing processes and regulatory compliance . GENERAL PROFILE Provides leadership and direction through individual… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provides technical expertise in support of an effective calibration program that supports daily clinical production and strategically prepares for commercial ... compliance mindset and passionately drives continuous improvement. Provides technical expertise in area of responsibility by effectively interfacing and… more
- Lundbeck (Miami, FL)
- …identifying mutually beneficial opportunities that meet the strategic needs of internal stakeholders. Participates in and contributes to projects and initiatives ... scientific exchange with thought leaders and communicates relevant information to internal stakeholders in order to define, update, and support medical strategies… more
- Merck & Co. (Rahway, NJ)
- …supplier network. You will lead the category and leverage strong communication skills and program management expertise to rapidly adapt and scale our program in ... oversight for the Company's renewable energy and carbon offset risk management program with support of business partners and third-party advisors.Lead the sourcing… more
- Merck & Co. (Rahway, NJ)
- …and reconciliation, query management, and database lock preparation/execution, in compliance with our company's Standard Operating Procedures (SOPs) and ICH-GCP ... lock tasks and activities.Interact and communicate with customers and stakeholders both internal and external to GDMS as well as our company when needed.Responsible… more
- Catalent (Manassas, VA)
- …Food Safety and Quality programs. This includes implementation and on-going program management/oversight on Safe Quality Foods (SQF) Certification, and its ... The position will develop, monitor, and validate the Sanitation Program to ensure that the manufacturing areas and the...Initiate Food Safety and Quality training as needed Manage internal and third party audits to maintain highest standard… more
- Catalent (Philadelphia, PA)
- …a Training Coordinator. As a Training Coordinator, you will support the Training Program and Quality Systems. This position will assist in the development and ... a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,...employee. The Role Support activities of the Manager, Training Program and the Training Lead.Cross train with Quality Systems… more
- Catalent (Manassas, VA)
- …and maintenance of all documentation related to the Quality System utilizing technical writing skills to ensure proper formatting, numbering, and organization of all ... and approval process for new documents and process deviations; Perform internal audits and document all non-conformance to support continuous improvement efforts;… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Corrective and Preventive Actions (CAPA) process, and is responsible for ensuring compliance within quality systems processes. Key Responsibilities Lead the CAPA ... program for the CAR-T manufacturing site. Oversee metrics, trending,...improvement of quality systems processes. Implement processes to ensure compliance with current Good Manufacturing Practices (cGMP). Manage multiple… more
- Merck & Co. (Durham, NC)
- …Services as a member of the EMSS. The EMSS team provides technical , calibration, maintenance, and engineering support for the manufacturing in Durham, NC.The ... Technician is recognized as a knowledgeable resource in maintenance, calibration, and technical areas and consulted in decision making. The individual in this role… more
- Merck & Co. (Durham, NC)
- …preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required.Work compliance systems for maintaining PM program and assessing ... Seeks ideas and information on how to improve customer service involving internal and external customers. Applies knowledge of the overall supply chain to… more
- Taiho Oncology (Dallas, TX)
- …and analytical processes, while working closely with regional peers, and internal /external matrix teams. Performance Objectives: Represents the company in a highly ... (academic & community setting) in a specific geography, provides on-label technical and administrative - information on company's products. Responsible for new… more
- Merck & Co. (Rahway, NJ)
- …for operational and equipment improvements.Overseeing the water chemistry-testing program to maintain standards for potable water, Demineralized water, ... deviations.The first-line supervision of twenty-four (24) licensed hourly operators. Ensures compliance with Code of Conduct, Local 68 IUOE Collective Bargaining… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director, Quality Operations will play a key role in ... critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent… more
