- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …meeting management, and resource coordination. Risk management planning (ie, risk identification, analysis, response planning, monitoring, and control ), ... Job DescriptionThe Trial Manager creates and ensures the successful execution of...and stakeholder expectations, facilitates cross-functional decision making, and performs risk management. Represents functional areas and GDMS on cross-functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and global regulations. Provide Quality Oversight for batch records, change controls , SOPs, non-conformances, risk assessments, and CAPAs associated with ... 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… more
- Catalent (San Diego, CA)
- … Control , including review, release and approval process. Site Change Control / change management programs. Site Risk Management. Site Supplier Management ... Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego,...Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies… 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter ... Part 11 in a manufacturing settingDemonstrated application of FMEA, Risk Analysis, Validation principles, guidelines, and industry best practiceDemonstrated history… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …eligible for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of Automation Engineering ... with Engineering, Automation, Validation, IT, Manufacturing, Quality Assurance and Quality Control , on project teams to facilitate design, transfer, and start-up of… 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 ... work is focused on those standards Ensure teams effectively identify "at risk " patient populations and utilize education and other relevant treatment guidelines to… 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 ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of R&D QA. Within assigned GPTs, facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and ... annual Quality Plan together with the supported GPTs including the quality risk assessments and inspection readiness components for the designated programs. Ensure… more
- Insmed Incorporated (Bridgewater, NJ)
- …This position will be accountable for all necessary strategic planning, risk management, operational execution and communication required for the successful and ... documentation - Target Product Profile Strategic Development plans, Dashboards, Risk assessments and other key tools to improve organizational processes.Challenge… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Supervisor of IT Operations Direct Reports: None Essential Functions IT Infrastructure Manager , covering GxP and non-GXP systems: Drive and maintain IT Operations ... needs Acts as IT Operations advocate, coordinating daily activities with the IT Manager (IT Infrastructure Owner) and team members Assists the IT Operations Partner… more
- Novo Nordisk Inc. (Durham, NC)
- …make what matters. The Position Work with team and vendors to ensure process control systems for new equipment and processes are in alignment with local and global ... connect to and be used in local manufacturing meeting all requirements. Relationships Manager , Senior Manager . Essential Functions Support plans to maintain &… more
- Merck & Co. (Rahway, NJ)
- …to ensure the business succeeds in utilizing these capabilities and we minimize our risk of outages that can impact our operations.The engineer will also work with ... the Print Product Manager to adopt and set a vision, roadmap, manage...levels, security requirements and other quality standards are met.Change Control Experience - ability to develop, document, and implement… more
- Merck & Co. (Durham, NC)
- …biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. ... performance objectives.Consults on an as-needed basis with next level manager on more complex decisions.Education Minimum Requirement:Bachelor's and/or Master's (or… more
- Tris Pharma (Monmouth Junction, NJ)
- …obligations Fosters a culture of quality-by-design in trial oversight and risk management across outsourced clinical trials, ensuring efficient issue resolution, ... risk mitigation and continuous improvement through strategic partnerships with...study work May also function as a Clinical Trial Manager (CTM), as neededRequirementsSpecial knowledge or skills needed and/or licenses… more
- Merck & Co. (Durham, NC)
- …osmosis skids, compressed gas systems) Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC))- Clean-In-Place (CIP) Systems- ... are guided by policies, procedures and business plan; receives guidance from manager . Contributes to the performance and results of the department. Identifies and… more
- Merck & Co. (Millsboro, DE)
- …eTime, Inspire.Compose, review, edit institutional SOPs.Serve as the hiring manager and trainer for Animal Services Managers.Coordinate promotions, transfers, or ... state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions control … more
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