- Merck & Co. (Rahway, NJ)
- …Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.- CMC RA : ... Validation, Manufacturing Quality Control , Manufacturing Scale-Up, Mentorship, Process Improvements, Project Management, Regulatory Submissions, Risk… more
- Merck & Co. (Rahway, NJ)
- …expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and ... experience with deep working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes.… more
- Merck & Co. (Rahway, NJ)
- …knowledge in QbDRequired Skills: Applied Engineering , Applied Engineering , Capital Management, Change Management, Chemical Process Development, ... Process Improvements, Product Commercialization, Product Lifecycle, Product Management, Regulatory Requirements, Results-Oriented, Social Collaboration, Stakeholder Engagement, Stakeholder Negotiations… more
- Merck & Co. (Rahway, NJ)
- …assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.CMC RA: Experience ... customers.Your participation will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to… more
- Merck & Co. (Rahway, NJ)
- …Managing Change Requests, People Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory ... (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality,… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... Requirement: -MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus 3-7 years experience in multiple… more
- Merck & Co. (Rahway, NJ)
- …Quality Control , Master Batch Records, Material Selection, Pharmaceutical Process Development, Production Planning, Regulatory Compliance, Shift Work, ... be opportunity for technicians to cross-train in other parts of the process including thaw, formulation, visual inspection, and sterile supply. These individuals are… more
- Merck & Co. (Rahway, NJ)
- …applying knowledge in drug and device product development, such as manufacturing process development and validation, design control , risk management, material ... strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design, development, and… more
- ValSource, Inc. (Rahway, NJ)
- …validation protocols and documents for a variety of utilities, facilities, and process equipment used in the FDA regulated pharmaceutical and biotech manufacturing ... client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves extensive travel to various… more
- Merck & Co. (Rahway, NJ)
- …Cost Management, Decision Making, Financial Acumen, GMP Compliance, Inventory Control Management, Logistics, Logistics Management, Management Process , Packaging ... relationships with key leaders and stakeholders, namely External Manufacturing, Quality/ Regulatory , Finance, Legal, and Shared Business Services, and other corporate… more
- Merck & Co. (Rahway, NJ)
- …Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Management ... Process , Manufacturing Scale-Up, Mentorship, Packaging Engineering , Process Optimization, Risk Management, Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …implementing, and optimizing automated laboratory systems to accelerate pharmaceutical process development while ensuring operational excellence and regulatory ... a Senior Scientist to join our Data-Rich Experimentation (DRE) organization, within Process Research & Developing Enabling Technologies (PR&D ET), located in Rahway,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …knowledge and expertise in support of GMP investigations, change controls, document control , process improvement, process validation and data ... efforts.Supports permanent inspection readiness and actively supports internal audits and regulatory inspections.Provides input to studies related to process … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management, resource planning, and fiscal awareness is preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ... while liaising with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …standards and GMP regulations.Conduct analytical testing of raw material/utility, in- process , or final product samples submitted to the QC laboratories.Perform ... quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/ Process Development.Job duties performed require routine exposure to and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …accurate budgeting, forecasting, and cost tracking.Ensure compliance with internal control processes, GxP standards, and regulatory requirements.Maintain ... process improvements, and risk mitigation.Directly support internal audits, regulatory inspections, and procurement-related documentation.Make recommendations for supplier selection… more
- Passaic Valley Sewerage Commission (Newark, NJ)
- Process Control Engineering and Regulatory Compliance Intern Overview IF YOU ARE A CURRENT PVSC EMPLOYEE PLEASE CLICK HERE ... of America Category: Process Control Description To provide process control engineering services for all physical, chemical and biological processes… more
- Capital One (New York, NY)
- …audit and regulatory exam readiness. Proven success overseeing complex regulatory requests, control testing, and regulatory remediation activities ... Senior Business Director - Network Surveillance Monitoring and Regulatory Strategy We are seeking a highly experienced strategic and execution-oriented Senior… more
- Actalent (Branchburg, NJ)
- Job Title: Regulatory Label SpecialistJob Description The Safety Data Sheet & Product Labeling Specialist is responsible for ensuring compliance with global ... regulatory requirements related to chemical safety documentation and product...affairs, labeling, and quality assurance. + Experience in document control , audit, and quality systems management. + Proficiency with… more
- ThermoFisher Scientific (Fair Lawn, NJ)
- …opportunities and implement changes. + Develop and maintain process control strategies, including SOPs and compliance with regulatory standards. + ... Chemical Division (LCD). This role involves close collaboration with equipment engineering , safety, quality, and operational units to develop and implement projects… more
