- Cipla (Central Islip, NY)
- …and regulatory requirements. Understanding of regulatory compliance, quality management systems and document control processes, and the ability to collaborate ... audit trail review of all quality softwares, ensure compliance within the systems etc. Maintaining regulatory compliance in accordance with cGMP and Perform Data… more
- Merck & Co. (Rahway, NJ)
- …vaccines portfolio. Our DRE organization is responsible for the invention and application of new data-rich tools to support the scientists across process research ... in an interdisciplinary, collaborative environment via invention, development, and application of cutting-edge process modeling including novel deep neural network… more
- Insmed Incorporated (NJ)
- …System Owner for the Learning Management System and compliance IT systems , which includes supporting GxP-regulated applications, while also functioning as strategic ... compliance IT systemsDrive compliance as IT system owner of the application , supporting internal and external audits to ensure regulatory complianceManage technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for providing engineering support for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. ... issues, deviations, corrections, remediation and improvement efforts of automation and controls systems for facility, equipment, systems and processes in support… more
- Merck & Co. (Durham, NC)
- …and applying domestic and international regulatory requirements Knowledge of Quality Systems within a GMP environment Demonstrated ability to establish and maintain ... obtaining meaningful audit observations "Subject Matter Expertise", including knowledge and demonstrated application in one or more of the following areas, based on… more
- Insmed Incorporated (NJ)
- …a key team member. Provide guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (eg ... security requirements. \tEnsure compliance and operational efficiency of validated systems through participating in release management, change control, periodic… more
- Twist BioScience (South San Francisco, CA)
- Sr IT Systems Administrator (in SSF, CA)Job Description:Twist is seeking a System Administrator who is responsible for endpoint engineering efforts and activities. ... This role is responsible for building, testing, and deploying OS and application packages and images throughout the organization. This user software lifecycle… more
- Insmed Incorporated (NJ)
- …a key team member. Provide guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state per ... security requirements. \tEnsure compliance and operational efficiency of validated systems through participating in release management, change control, periodic… more
- Merck & Co. (North Wales, PA)
- …span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.-The incumbent is responsible for the ... clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertiseDesigns and develops complex programming algorithmsAbility… more
- Merck & Co. (Durham, NC)
- …technology transfer focusing on either upstream, downstream, and/or culture media/support systems .Off-shift and weekend coverage will be required based on business ... qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates… more
