- Merck & Co. (North Wales, PA)
- …other functional areas (eg, Clinical Research, Safety Assessment).Supports maintenance (eg, quality compliance and life cycle management) of VID ... strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as… more
- Merck & Co. (Durham, NC)
- …will be responsible for activities that support Good Manufacturing Practice and regulatory compliance during product manufacturing within the respective VMF's to ... packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal… more
- Aequor (West Greenwich, RI)
- …as necessary. 6. Perform general laboratory housekeeping activities. 7. Maintain training compliance and proficiency. 8. At all times, comply with safety guidelines, ... cGMPs/CFRs and other applicable regulatory requirements. Shift: Tuesday - Friday shift schedule. Skills: Previous lab experience is preferred.Basic Qualifications:… more
- Eisai, Inc (Nutley, NJ)
- …educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new ... crisis management.Manage IT training programs and conduct Segregation of Duties reviews. Regulatory Compliance Activities:Collaborate with legal and compliance… more
- Catalent (St. Petersburg, FL)
- …manufacturing challenges.Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, ... Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The Department… more
- Merck & Co. (North Wales, PA)
- … Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical ... or the device constituent of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical… more
- Insmed Incorporated (Bridgewater, NJ)
- …years relevant experience requiredExtensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug ... York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director, Quality Operations will… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk ... reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior ... Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal ... or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight… more
- Catalent (Philadelphia, PA)
- …guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality ... and effective quality system that delivers reliable, high- quality products that meet all customer and regulatory...have responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control… more
- Merck & Co. (Durham, NC)
- …while ensuring product quality and optimized maintenance processes, regulatory compliance , employee and environmental safety, integration of new/existing ... interaction/partnership with employees from other departments (Operations, Technical, Automation, Quality )Interacts with representatives from regulatory agenciesInteracts with… more
- Merck & Co. (Durham, NC)
- …or review and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key ... Mass Spec equipment, supporting Bulk Chemical equipment, implementations of process change control , Delta V Network and troubleshooting in compliance with system… more
- Merck & Co. (Rahway, NJ)
- …also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality , and our partners in the commercialization and ... effective technical and communication skills, an effective understanding of the regulatory environment, and a-vision to influence the regulatory … more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required. Responsible for… more
- Merck & Co. (Durham, NC)
- …and safe maintenance and repair of equipment using Hazardous Energy Control Procedures. Compliance with current good manufacturing procedures(cGMP), safety and ... written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… 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
- Novo Nordisk Inc. (Durham, NC)
- …areas of Systematic Problem Solving, process improvement, & project management Operate within compliance with a Quality Mindset that focuses on risk management & ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...what matters. The Position Improve reliability of the process control systems to meet current & projected customer, business… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …functionalities and best practices to drive efficiency and effectiveness while maintaining regulatory compliance . Embrace and promote Agile principles and values ... Warehouse, Materials Planning, Work Centers, Bill of Materials / Recipes, Costing and Quality Inspection attributes. This role will partner with the IT team and… more
- BioAgilytix (Durham, NC)
- …you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical, scientific, and compliance review of data and ... You are the bridge between the lab and the quality assurance team, combining observations on regulatory ...the quality assurance team, combining observations on regulatory requirements with your knowledge of plate-based assays, cell… more
