- Novo Nordisk Inc. (Durham, NC)
- …presence & process confirmation on shop floor. Relationships Manager, Quality Assurance . Essential Functions Ensures site compliance with Regulations, ISO standards, ... Participates in process confirmations & Go Look Sees Evaluates trend & report data for QMRs & APR reports Other accountabilities, as assigned. Physical Requirements… more
- Merck & Co. (North Wales, PA)
- …internal and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management , Clinical and other project stakeholders.-Primary ... of deliverable quality and process compliance.Familiarity with statistical and clinical data management conceptsPreferred Experience and Skills: Strong working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manufacturing, facility, and quality controls areas and operations.Review and compile data for migration into electronic management system and archive.Generate ... diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training for...functions of GMP QA Department such as Audit, Quality Management System, Pharma Product, External Supplier Management … more
- Insmed Incorporated (Bridgewater, NJ)
- …they follow relevant regulatory GMPs and global company policies & proceduresLead overall management of Quality Assurance programs to support the QC lab and ... Assurance department.Support Statistical Trending of Manufacturing and Analytical Data .Additional duties as assigned QualificationsBS degree in Chemistry, Engineering,… more
- Merck & Co. (North Wales, PA)
- …expertise and discretion.Preferred: Cross-functional experience in clinical research (eg, monitoring, data management , clinical quality assurance , study ... SDIL is responsible for the integration between our source systems (primarily Data Management Workbench (DMW)), our company IT Data hub and Supplier's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … assurance initiatives including but not limited to utilization management controls, 340B compliance, and contract compliance. Relationships This individual ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- BioAgilytix (Durham, NC)
- …therapeutics to the patients who need them.Our clients trust us to deliver excellence in data and bioanalysis and in this role and you will be a critical part of ... our beginning-to-end client data quality processes. Through your technical reviews of raw...are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your… more
- Merck & Co. (North Wales, PA)
- …with Common Data Model (CDM)Expertise in statistics, clinical and data management concepts as applied to drug/vaccine development within the ... analysis and reporting deliverables for Research & Development projects ( data , analyses, tables, graphics, listings)Excellent project management skills;… more
- Tris Pharma (Monmouth Junction, NJ)
- …New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, ... oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are… more
- Merck & Co. (North Wales, PA)
- …and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine regulatory ... through the entire product lifecycle.Key areas of focus include:the assurance of deliverable quality and process compliance,effective deliverable development… more
- BioAgilytix (Durham, NC)
- …quality and compliance in our solutions. Our clients trust us to deliver excellence in data and bioanalysis, and this role is the last destination before our data ... then advise on corrective action, which leads us to the ultimate goal of data quality and integrity for our customers. We are looking for candidates who have… more
- Catalent (Philadelphia, PA)
- …Materials Sampling Quality Assurance , Regulatory and Compliance Quality Assurance , and Validation Quality Assurance . Management responsibilities ... Director of Quality is responsible for providing leadership and Quality Management support within each of the Clinical development supply division. This… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …opportunities Review relevant Investigations, Change Control, and CAPA(s)Work with Area Management to drive Quality Culture Providing Quality Assurance oversight ... across multiple shifts to oversee all quality aspects within the Quality Assurance Unit ensuring compliance with federal regulations for current Good Manufacturing… more
- Merck & Co. (North Wales, PA)
- …for ensuring the clinical relevance and medical accuracy of data /information in promotional materials, external communications and field-based employee training. ... responsible for ensuring the clinical relevance and medical accuracy of data /information in promotional materials, external communications and Field Based Employee… more
- Catalent (Manassas, VA)
- …Foods (SQF) Certification, and its initiatives. This position also requires Quality Control data base management and control over product specifications. The SQF ... analytical services to solve difficult development and manufacturing challenges.The Quality Assurance Supervisor will lead Food Safety and Quality programs. This… more
- Catalent (Harman, WV)
- Position Summary The Director, Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management , CAPA tracking, change control, risk management ,...device industry performing direct hands-on work in a Quality Assurance /Quality Control function with a strong familiarity of general… more
- Novo Nordisk Inc. (Boulder, CO)
- …Lead works with Chemical Development, Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance . The Technical Team Lead, API ... from laboratory to pilot plant scale Author and/or review batch documentation ( data capture forms, solution preparation forms, work instructions, etc.) and generate… more
- Merck & Co. (North Wales, PA)
- …an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM standardsExperience ... in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, graphics, listings)A project leader; completes tasks independently… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and non-GXP systems: Drive and maintain IT Operations Service delivery and Incident Management at Site, being recognized as the single point of contact (SPOC), for ... on LAN and WAN) Design, Support, troubleshoot, and maintain network communications ( data and voice) across facility Design, Administer and maintain Active Directory,… more
- Merck & Co. (North Wales, PA)
- …an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM standardsDemonstrated ... in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, graphics, listings)Strong project management ...success in the assurance of deliverable quality and process compliance.Strategic thinking -… more
