- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , ... standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event,… more
- Novo Nordisk Inc. (Boulder, CO)
- …and in a manner which meets their expectations Acts in role of lead Quality Assurance for NN Boulder Change Control process, including review and disposition ... analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals...Acts as SME and local Super User for NN systems , specifically for the Change Control and… more
- Novo Nordisk Inc. (Durham, NC)
- …with stakeholders through engagement & positive cooperation Perform & oversee change control activities for QC equipment & systems Support systematic problem ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Catalent (St. Petersburg, FL)
- …responsibility for Quality aspects including but not limited to Quality Systems , Finished Product Batch Release, Training, Internal/External Audits, ... Computerized System Validation (CSV) guidelines, policies, and procedures for control systems , automation, analytical equipment, and IT applications.Ensure… more
- Catalent (St. Petersburg, FL)
- …the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, Change Control , Client interface, Lab Investigations, ... with other functional areas (eg Product Development, Operations, Customer Service, Validation, Quality Control , etc.) to ensure continued compliance for the… more
- Merck & Co. (Rahway, NJ)
- …CRA manager and/or functional vendor and internal management as needed. Performs Quality control visits as required. Leads local study teams to high ... with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The… more
- Catalent (St. Petersburg, FL)
- …has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control .The QA Product Manager ... QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Teknika Quality Assurance group ensures every single material inside our products is manufactured, tested, and distributed in alignment with our ... incredibly high standards of quality . The Quality Assurance Associate Director will...on ensuring facility and personnel remains in state of control based on Sterility Assurance requirements ensuring an integral… more
- Novo Nordisk Inc. (Durham, NC)
- …duties & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential Functions Ensures site compliance with ... for Quality approval - components/raw material, batch records, change control requests, deviations & validation documents Performs QA presence & process… more
- Insmed Incorporated (Bridgewater, NJ)
- …and define priorities.Anticipate upcoming tasks based on the submission timelines.Perform quality control checks and coordinate comment resolution with ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …engineers in development of metrological specifications for new equipmentDevelop control charts and statistical process controls for calibration standards and ... in the implementation and maintenance of ISO 17025 (if applicable) Quality Management SystemComplete documentation and reports of all calibration and maintenance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and curricula development experience including oversight and administration of validated electronic systems such as LMS or other quality management systems ... or Global project teams. This position has advanced skills in technology systems , including word processing software and data management software, and business… more
- Eisai, Inc (Nutley, NJ)
- …Information System Manager (CISM), Certified in Risk and Information Systems Control (CRISC), Certified Information Systems Auditor (CISA), ... review adherence to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of regulatory, commercial,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …, instrumentation, and computerized systems .Knowledge of quality systems including exception management, change control , document control .Knowledge ... investigations, and process improvement projects.Identify, and oversee changes within quality systems .Assure equipment maintenance and calibration, and internal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies ... is an exempt level position responsible for reviewing all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related… more
- Merck & Co. (Rahway, NJ)
- …a deep understanding of how our clients navigate business processes and enabling systems to deliver their job responsibilities. In this role, the candidate will ... improvements to our infrastructure (eg knowledge management, training, and enabling systems ) and drive initiatives on that roadmap that improve processes and… more
- Novo Nordisk Inc. (Durham, NC)
- …Relationships Shift Manager . Essential Functions Setup, operate, monitor & control equipment, systems & processes Clean & sanitize manufacturing, filling ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...fellow employees in areas of expertise & aggressively learn systems & equipment outside of own expertise (with the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …on and manage multi-disciplined projects, with minimal supervision Understanding/application of quality systems Support of Health Authority inspections Possesses ... manufacturing operations. Focus areas may include Training, Documentation, Deviations, Change Control and Projects. Drives the coordination and execution of process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …driving compliance. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties will be assigned, as ... Manufacturing Operations, Quality Assurance, Engineering and Validation, Quality Control and Warehouse Operations. Requirements A...& Development is preferred. Proficient in the use of quality systems such as SAP. Experience working… more
- BioAgilytix (Boston, MA)
- …according to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance ... technical reviews of documents prior to review by the project manager (eg, Bioanalytical Project Manager (BPM), Principal Investigator)independently creating… more
