- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO(s) provide timely input and generate documents in a timely manner and with quality (eg communication plan, site monitoring plan, etc.) as per study ... Has primary accountability for operational study level time, cost and quality deliverables.Lead the development of the clinical study plan including critical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, ... NJ. Role Overview The Quality Compliance- Lead Auditor CAR-T is responsible for regulatory...required, run reports and conduct data analysis to support monitoring of key performance indicators; support the preparation of… more
- Novo Nordisk Inc. (Stamford, CT)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Aequor (Thousand Oaks, CA)
- …maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books. Preferred Qualifications Ability ... to adhere to regulatory requirements, written procedures and safety guidelines? Ability to evaluate documentation/data according to company and regulatory guidelines? Ability to organize work, handle multiple priorities and meet deadlines? Strong written and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …key stakeholders in developing and implementing policies, procedures, training, and monitoring to embed privacy considerations into key business processes, as well ... based on continued maintenance and upkeep of data maps, as well as monitoring and assessment of evolving privacy laws and regulations.- Manage and respond to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality , and expedite the preparation of oncology compound regulatory submission. It ... programming standard on datasets and TFLs to improve efficiency and quality .Responsibilities- By leading internal programming contractor or by self, perform… more
- Merck & Co. (Rahway, NJ)
- …energy savings initiatives, improved reliability, operability and maintainability.-REES Environmental Monitoring System : The Rahway site utilizes a single ... environmental system (REES) to support the monitoring and alarming of multiple areas onsite included but not limited to areas for our company's Research… more
- Other Executive (Worcester, MA)
- …Ensures processes for viability of performance improvement programs. Identifies key quality indicators for monitoring and evaluating. Participates in the ... enterprise, we are united by our mission to deliver quality , compassionate care in the communities we serve. For...their first thirty (30) days of work. Responsible for monitoring competency levels of employees and providing staff development… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The QC Microbiology Supervisor leads, and monitoring the daily operations, activities, and workflow for the laboratory personnel. Additionally, you will implement ... of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, USP, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …programs Assists in the creation, tracking and completion of maintenance related quality events, CAPAs, and Out of Tolerance (OOT) situations Conducts basic risk ... on an EHS first mindset, a Right First-Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous improvement… more
- Merck & Co. (Rahway, NJ)
- …with-ICH/GCP and country regulations, our Company policies and procedures, quality standards and-adverse event reporting requirements internally and externally.The ... ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.Reviews… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …I will perform Microbiological laboratory testing associated with Environmental Monitoring (EM), Water for Injection (WFI), and product specific Microbiological ... samples. Additionally, the Microbiologist will be trained to perform Environmental Monitoring (EM) and Water for Injection (WFI) sampling in support of cGMP… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations,-our company's policies and procedures, quality standards and adverse event reporting-requirements internally and externally.The ... with-ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.o… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma. Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role Overview The QC Microbiology Data Reviewer is ... for reviewing microbiology data and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... execution of clinical trials, the drafting of medical/ scientific documents, safety monitoring , and data analyses. In this high visibility position, the candidate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance. Proactively track, monitor and report trial risks,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …templates Serve as an SME for global initiatives related to quality /compliance/validation (APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring ... participation in a variety of cross functional CMC and quality forum under the Joint Manufacturing Committee in the...in a validated and controlled state and consistently delivers quality product meeting or exceeding the standard of various… more
- Kaiser Permanente (Atlanta, GA)
- …of care for hospitalized members by carrying out daily utilization and quality review, monitoring for inefficiencies and opportunities to improve care, ... case managers, home care reviewers, social workers, members and providers, quality improvement reviews, and education of the member/family, provider and hospital… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... case processing, product use and disease state knowledge) Develop and maintain quality check-points to track and evaluate employee's training progress and provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality , and other affiliates. External stakeholders include Healthcare professionals,… more
