- 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
- 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
- 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. (Rahway, NJ)
- …workforce planning, and other strategic activities as required. Analyzes headcount data to provide budget forecasts to management .Responsibility for oversight ... Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management , and can represent the Company in forums on their area of… more
- Eisai, Inc (Nutley, NJ)
- …from EIT and leaders across regions in Compliance, Ethics, Risk Management , Legal, Data Privacy, and Information Protection.Security Responsibilities:Monitor and ... GxP standards.Industry-related legal, compliance, information security, or business continuity management certification is advantageous.Prior audit/ assurance experience is… more
- Merck & Co. (Rahway, NJ)
- …the data to drive decisions on programs improvements.Support project management activities (manage project plans, track, and follow-up on actions).Ensure that ... along with the global teams to develop options and alternative solutions.Category management ensuring compliance to the procurement process and supporting the design… more
- Merck & Co. (Rahway, NJ)
- …and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine regulatory ... the entire product lifecycle.Key areas of focus include (1) the assurance of deliverable quality and process compliance, (2) effective deliverable development… 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
- Catalent (St. Petersburg, FL)
- …Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The ... QC, and training to provide training and coaching on CSV projects and data integrity initiatives.Develop and execute plans, procedures, and requirements to address … 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 (Manassas, VA)
- POSITION SUMMARYThe Quality Assurance Specialist I is responsible for inspection and verification of the products and production processes along all the production ... ensure adherence to company quality standards procedures and policies. Inform the QA management if any out of specification or any deviations are found. Comply with… 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
- Merck & Co. (Rahway, NJ)
- …with cross functional scientists including, Statistics, Clinical, Regulatory, QP2, CSRM, Data Management and Statistical Programming to plan for the ... Job DescriptionResponsibilities:Responsible for both people and project management and is accountable to set strategy for the delivery of high quality and compliant… 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
- Aequor (New York, NY)
- …an occupational nursing professional Minimum experience of 1-3 years in case management , utilization review and/or quality assurance Experience in episodic care, ... services to employees within regulated scope of practice and disability case management .Experience/Education: MS/NP in nursing degree and current NP license in New… 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
- Aequor (Bothell, WA)
- …specifications and SOPs. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data . May provide guidance ... to less experienced staff. Provides sitewide support during daily walkthroughs of GMP areas. Requirements: BS, in Biology, Chemistry or related discipline, or its equivalent is preferred. 2&plus years of relevant experience in a regulated environment with at… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …actions, and change control documents. The incumbent will be expected to gather data from various sources across the organization in order to lead and perform ... team that includes but is not limited to quality assurance , quality control, operations, engineering, maintenance, calibration, safety, supplier quality,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... also responsible for supporting other processes in the Novo Nordisk Quality Management System as well as driving continuous improvement projects within the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility Perform internal housekeeping audits Perform analysis on quality indicating data and identifying trends Provide oversight for trending of quality compliance ... experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, or cell therapy Knowledge of… more
