- Novo Nordisk Inc. (Durham, NC)
- …completeness & maintenance of validated state per corporate requirements. Change control responsible for QC equipment. Collaboration & coordination with IT, ... the right quality, cost & timely completion of all deliverables. Relationships Manager . Essential Functions Ensure accuracy & compliance of validation & equipment… more
- Aequor (Seattle, WA)
- …Therapy Above-site organization, including the document approvals, document change control process , periodic review and system reporting. ... Job Description: Top Skills: - 2&plus years of Document Control & Reporting Experience, - Veeva experience preferred - Technical troubleshooting - Self motivated,… more
- Catalent (Manassas, VA)
- …formulations to help create engaging new products consumers will love.The Document Control Specialist - 2nd Shift is responsible for creating and maintaining the ... Quality Plans, and any other documents as required.Manage the routing and approval process for new documents and process deviations; Perform internal audits and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) and/or ... Visits Reports and escalates performance issues and training needs to CRA- Manager and/or functional vendor and internal management as needed.o Performs Quality… more
- Catalent (St. Petersburg, FL)
- …Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control .The QA Product Manager provides customer service, with the highest ... QA Product Manager Position SummaryThe QA Product Manager ...technical documents including but not limited to: a) change controls and associated Master documents, including but not limited… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and production engineers in development of metrological specifications for new equipmentDevelop control charts and statistical process controls for ... calibration standards and resultsAssist in the implementation and maintenance of ISO 17025 (if applicable) Quality Management SystemComplete documentation and reports of all calibration and maintenance actionExperience Requirements5 years of solid calibration… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...with responsibilities for providing quality oversight for the manufacturing process , equipment, and associated deviations and investigations within a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …artifacts o Security and protection of organizational data assets o Access Control leveraging administrative controls of data access rights for cross-functional ... as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as assigned.-… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating… more
- Merck & Co. (Rahway, NJ)
- …DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities ... limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager ...function and cross-functionally.Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial… more
- Novo Nordisk Inc. (Durham, NC)
- …responsible for activities related to BMS & alarm handling. Relationships Manager . Essential Functions Resource scheduling as related to third party instrument ... instrument performance & responds to potential issues Contributes to process confirmations Maintains training qualifications on time. Supports training others… more
- Catalent (San Diego, CA)
- …audits (including coordination with IACP program). Site Environmental Monitoring, Site Label Control , including review, release and approval process . Site Change ... Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego,...and executed Batch Records for cGMP compliance and clarity.Oversee process integration and procedural harmonization with other clinical supply… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Manager of Automation Engineering leads Automation Engineers and contractors responsible for instrumentation and controls of manufacturing ... operations of the Automation Engineering department.Generate, review, approve and control departmental documentation (eg, SOPs and system reports). Participate in… more
- Novo Nordisk Inc. (West Palm Beach, FL)
- …with superior ability to lead through change. Relationships Internally, the Educator Manager (EM) reports to a Region Business Director (RBD) in the Commercial ... regulatory/legal mandates Review and audit direct reports' expense reports. Exercise prudent control of field expenses Ensure timely and accurate submission of other… more
- Merck & Co. (Ames, IA)
- …aid in delivery of product to customers, ie International Registration, Quality Control , Quality Assurance, Production, etc.Provide Sales force training as well as ... inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here...you need an accommodation during the application or hiring process . We are an Equal Opportunity Employer, committed to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …assurance initiatives including but not limited to utilization management controls , 340B compliance, and contract compliance. Relationships This individual ... contributor role reports to the Sr. Manager of Business Assurance and works closely with various...around commercial rebate exclusions, formulary compliance, and utilization management controls and reports out to internal leadership and account… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …years' experience in the biotech/pharmaceutical industry in validation, quality management, process controls , and continuous improvement in an FDA-regulated ... Serve as a technical resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the quality and process … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the successful execution of brand-level marketing ... including coordination with external suppliers and agencies. Ensure quality control of marketing material. Ensure quality control ...and motivate others We commit to an inclusive recruitment process and equality of opportunity for all our job… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to realize your potential? The Position The Manager - Market Access Insights assesses product and customer performance for all ... decisions by conducting longitudinal patient-level data analyses, including payer control impact on patient abandonment, adherence and persistence. Collaborates with… more
