- Merck & Co. (Rahway, NJ)
- …with configuration management .Knowledge of published regulatory agency data integrity, computer software assurance guidance.Moderate level of ... inspection activities.Deliver stewardship for company's corporate initiatives from a Quality Assurance perspective, such as the Data Governance and Corporate… 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
- 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
- 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
- Option Care Health (Dublin, OH)
- …problems and to make appropriate medication therapy recommendations.Assists in the assurance of continuity in pharmaceutical care to and from the home ... to the supervising pharmacist.Assists with product purchasing, inventory and equipment management . Orders the correct drug products from the wholesaler or supplier,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and quality assurance matters in order to achieve a stable supply.- Data Management : Develop performance report for CMO's based on manufacturing, product ... developing performance report including key performance indicators (KPI's).Responsibilities- CMO Management : Develop and maintain a robust relationship with CMOs… 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
- American Honda Motor Co Inc (Marysville, OH)
- …Future!LocationMarysville, OhioJob PurposeThe AHM Audit Division is an independent, objective assurance and consulting activity designed to add value and improve an ... (NAROB) and senior executives across North America to strengthen risk management , internal controls, and governance processes among Honda and affilated operations… more
- American Honda Motor Co Inc (Marysville, OH)
- …will provide guidance and leadership to the Executive Support, Client Quality Assurance , and Deskside Support team. Conduct gap analysis to identify strengths and ... coaching, and mentoring, integrated with consistent and effective individual performance Management . Ensure the team is motivated, engaged, and inspired to achieve… 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
- 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
- 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
- American Honda Motor Co Inc (Marysville, OH)
- …North America. Responsible for evaluating negative delivery, production, inventory management , plant/equipment, sub-supplier management , packaging control and/or ... and parts. This includes cross-functional collaboration in areas within Supply Chain Management , as well as New Model, Procurement, and Supplier Assurance … more
- BioAgilytix (Durham, NC)
- …and open communications with all departments, including Quality Control, Quality Assurance and Sample Management Prepare Sample Analysis worklists Support ... received and discrepancy / reconciliation activities Coordinate with Central Lab and/or Data Analytic group for Data Transfer Agreement setup and file… 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
- 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
