- Merck & Co. (Rahway, NJ)
- …Description: Device Development Associate Principal Scientist - Development Strategy, Design Controls and Risk Management Our company's Device Development (DD) ... be responsible for leading and implementing medical device and combination product design controls and risk management activities for both new products and… more
- Merck & Co. (Rahway, NJ)
- …design and development, manufacturing process development, qualification and validation, design controls and device risk management techniques to positively ... (eg engineering design, engineering analysis and testing, medical device design controls , risk management, test method/fixture development, design verification… more
- Merck & Co. (Rahway, NJ)
- …- You will learn how to evaluate business operations, processes, and internal controls to effectively complete risk -based audits. Individuals are ... of IT internal audit engagements to assess the adequacy of internal controls . This includes performing walkthroughs and testing information technology… more
- Merck & Co. (Rahway, NJ)
- …of the company's strategy; this includes a deeper knowledge of internal controls , business compliance, and risk management. Individuals will be based ... audits, both domestic and abroad to maintain a strong internal control environment at our Company.Opportunity to...how to evaluate business operations, processes, and internal controls to effectively complete risk… more
- Merck & Co. (Rahway, NJ)
- …Expertise:Utilize extensive experience in design controls , device transfer, control strategies device risk management, and design verification testing ... prefilled syringes, and complex drug delivery systems.Proven expertise in design controls , risk analysis, control strategies, design verification… more
- Merck & Co. (Rahway, NJ)
- …of the company's strategy; this includes a deeper knowledge of internal controls , business compliance, and risk management. Individuals will be based ... audits, both domestic and abroad to maintain a strong internal control environment at our Company.Under the...how to evaluate business operations, processes, and internal controls to effectively complete risk… more
- Merck & Co. (Millsboro, DE)
- …tools, definition of deliverables, definition of roles and responsibilities, risk identification/tracking/mitigation and business acumen.Coordinates and tracks ... business need.Assures consistent application of standardized work, engineering controls , and process analytical technology.Authors experimental protocols and reports… more
- Merck & Co. (Rahway, NJ)
- …the EQA Compliance/System team, which will provide Quality oversight of Quality and Business processes with EQA related to Quality Risk Management.- The ... (EQA) processes against approved quality manual documents and/or ensuring robust business systems in compliance with our Company policies.- The incumbent will… more
- Merck & Co. (Rahway, NJ)
- …DescriptionOur company's Information Technology (IT) division partners with colleagues across the business to help serve our patients and customers around the world. ... SAP Global Template asset, delivering enterprise-level capabilities through harmonized business processes and data.-The team is responsible for the operation… more
- Tris Pharma (Monmouth Junction, NJ)
- …and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance ... Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating… more
- Merck & Co. (North Wales, PA)
- …for a prescription medicine , will work closely with agency partners, internal brand colleagues, promotions, internal communications, pricing, policy, legal, ... development of brand and market access strategy in collaboration with internal functions (Organized Customer Access and Reimbursement, Marketing, Integrated Account… more
- Merck & Co. (Rahway, NJ)
- …Health Global Supplier Management teams. Our international team partners with the business to ensure efficient acquisition of goods and services that enables the ... with cross-functional teams and shape our sourcing strategies to drive business success.The Category Manager will be actively engaged in the development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …act as the safety expert to establish and maintain processes, procedures and controls to ensure compliance with all relevant internal and external requirements ... authorities: FDA and Health Canada AE and MDR and relevant vendors. Internal stakeholders: Global Safety, QPPV office, Global Development, Product Supply, Regulatory… more
- Merck & Co. (North Wales, PA)
- …is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises ... The Principal Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems team, ad hoc, for activities such as annual product review, site risk register, or internal quality agreements.Develops and delivers training for ... Responsibilities Successfully support the implementation, execution, and improvement of the internal audit process.Support the planning and execution of internal … more
- Merck & Co. (Rahway, NJ)
- …modeling, end-to-end flowsheets and digital twins, model-based process controls , plant and process-economics (including facility fit, cadence, scheduling, ... results to actual, experimental outcomes in projects. Present at internal and external forums (conferences, publications).-Lead external collaborations (with… more
- Merck & Co. (Rahway, NJ)
- …CMOs as the Quality liaison between the external partner and the internal company personnel. The successful candidate will provide technical expertise in validation, ... quality systems, deviations, change control , equipment qualifications, and auditing. Join our dynamic team and play a key role in ensuring the highest quality… more
- Merck & Co. (Rahway, NJ)
- …guiding product and process development.Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices ... and/or department via presentations to governance committees and other internal audiences.Partnering with director-level management to develop and execute scientific… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... (eg washers, autoclaves, tube welders/sealers)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)-Clean-In-Place (CIP)… more
- Merck & Co. (Rahway, NJ)
- …Clinical Trial processes as well as quality management systems and quality control tools is required.Direct knowledge of GCP/ICH and worldwide Regulatory Health ... written communication skills in an international environment.Well versed in risk -based approaches to inspection preparation/management.Excellent project management and organizational… more
