- Merck & Co. (Rahway, NJ)
- …Drug Product Development, Estimation and Planning, General Safety, Manufacturing Quality Control , Mechanical Troubleshooting, Pharmaceutical Process Development, ... Control Automation, Process Optimization, Product Formulation, Project Management, Quality Control Management, Regulatory Compliance, Regulatory Issues,… more
- Merck & Co. (Rahway, NJ)
- …FDA Regulations, Good Manufacturing Practices (GMP), Laboratory Techniques, Manufacturing Quality Control , Master Batch Records, Material Selection, ... closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success and performance… more
- Formation Bio (New York, NY)
- …vendor relationships and governance, holding external partners to high standards of quality , cost control , and on-time deliverables. Serve as the Operations ... Lead for clinical assets and associated studies. Step in as the Clinical Project Manager when needs arise. Operational Strategy and Leadership Develop and implement operational strategies for programs and clinical studies. Collaborate with cross-functional… more
- Merck & Co. (Rahway, NJ)
- …microscopy and chromatography.Collaborate with cross-functional teams, including research, development, quality control , and regulatory affairs, to ensure ... Leadership, Pharmaceutical Biology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance, Regulatory… more
- Merck & Co. (Rahway, NJ)
- …clinical and scientific contacts and key opinion leaders in relevant fields.Conduct quality control inspections of study protocol, study documentation files and ... Study ReportMaintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed of the study progress.May… more
- Reed Smith LLP (New York, NY)
- …developing persuasive RFP responses and client pitches, with rigorous attention to quality control , deadlines and brand consistency. Job Duties and ... to detail and accuracy are critical skills necessary for ensuring precision and quality in all tasks and responsibilities. Ability to use independent judgment and… more
- NewYork-Presbyterian (New York, NY)
- …respiratory specimens and others. Perform Microscopic examination of the samples and conduct quality control procedures and assist in the evaluation of new ... equipment, reagents and methodologies. Calibrate and maintain advanced lab instrumentation including Biofire, Bactec FX, Cobas 6800, Cepheid, and Maldi-Tof . Research and establish new procedures to improve laboratory operations. This is a day shift position… more
- Merck & Co. (Rahway, NJ)
- …procedures, Training, and SOPs for all GxP automation systems.Lead integration of control systems with MES, Quality , and Batch Reporting applications.Understand ... operations, and qualification needs.Execute and develop appropriate system validation, change control , and testing documentation in partnership with project CQV and… more
- NewYork-Presbyterian (Manhattan, NY)
- …to other Generalist Laboratory Technologists. Troubleshoot instruments and methods. Perform all quality control procedures and assist in the evaluation of new ... equipment, reagents and methodologies. Calibrate and maintain lab instrumentation. Research and establish new procedures to improve laboratory operations. This is a Night shift position working Monday - Friday plus rotating weekends and holidays. Location is… more
- Merck & Co. (Rahway, NJ)
- …for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes ... execution of device development strategies and drive continuous improvement in design control and risk management processes. This individual will be expected to… more
- SOFIE (Totowa, NJ)
- …on existing or new equipment. Collaborate with other production radiochemists and quality control chemists as required to ensure successful protocol development ... products from concept to reality-ensuring every process meets the highest standards of quality and regulatory compliance (21 CFR 211 and 212). If you're driven by… more
- SOFIE (Totowa, NJ)
- …on existing or new equipment. Collaborate with other production radiochemists and quality control chemists as required to ensure successful protocol development ... and analysis of clinical-grade radiopharmaceuticals, validate these methodologies against quality requirements, and implement them for regular production of… more
- The LiRo Group (New York, NY)
- …with Construction/Design teams to coordinate BIM content and approaches, model exchanges, quality control , and delivery. Visualize and create reports on an ... ongoing basis. Troubleshoot BIM software and platform issues and stay current with emerging tools and technologies. Qualifications Required Qualifications: Bachelor's degree or higher in Architecture, Engineering, Civil Engineering, Construction Management, or… more
- Merck & Co. (Rahway, NJ)
- …oversee device risk management activities to ensure the delivery of high- quality products and efficient manufacturing processes. The role requires extensive ... hazard analyses and Failure Modes and Effects Analysis (FMEA), implementing risk control measures, and performing overall device risk evaluations in compliance with… more
- Merck & Co. (Rahway, NJ)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success and performance ... PAS-X is preferable.GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations.- Able to report… more
- Merck & Co. (Rahway, NJ)
- …and process audits, both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will be expected to lead ... papers (including walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in the writing of… more
- ValSource, Inc. (Rahway, NJ)
- …ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves extensive travel to various client ... Requirements Minimum of 7 years’ experience with increasing responsibility in validation/ quality service and project management of life sciences, biotech or other… more
- Merck & Co. (Rahway, NJ)
- …molecular biology and immunoassay techniques - Strong background in ana lyt ical control st r ategy development and execution - Demonstrated ability to develop ... Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics… more
- Merck & Co. (Rahway, NJ)
- …our processes and drive enhanced decision making for improving the speed and quality of development for diverse medicines and vaccines. In this Senior Scientist ... Experience in developing novel process models for dynamical systems, process control , or digital twins for chemical or biological systems through physics-based,… more
