- Aptyx (Charlotte, NC)
- …Matrix Develop and engineer disposable medical devices from concept to production Hands-on products and process development of catheters and other disposable ... including the creation of PM procedure as necessary Support of equipment maintenance , as appropriate for skills and knowledge Support or perform equipment re-entry… more
- Tris Pharma (Monmouth Junction, NJ)
- …Agency (DEA) requirements are being followed with respect to the production of controlled substances Reports and investigates any deviations from processes ... or procedures Maintains a presence on the production floor at all times; Trains new employees and...documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc. Strong record keeping… more
- Eisai, Inc (Exton, PA)
- …for the performance of all critical biologics manufacturing steps per production scheduling, material staging, equipment set-up, and GMP operations in the ... ownership in achieving high-quality output on time. Coordinate equipment maintenance , calibration, and validation with appropriate internal departments. Troubleshoot… more
- Cipla (Fall River, MA)
- …is responsible for the creation and revision of new and existing GMP batch production records as well as SOP's. In this role the Documentation Specialist adheres to ... cGMP records and SOP's. Knowledge of GDP. Creation and maintenance of batch record and cGMP documentation templates. Closure...audit part of team. Planning of batches as per production plan. Knowledge of audits and compliance . Professional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP ... groups to establish a strong, compliant CQV program to enable robust production , testing and release of product to patients.Key Responsibilities Executes the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight and guidance during the investigation of events that occur in the production of a personalized cell therapy product in a sterile GMP environment. The ... determine resolution for end-to-end manufacturing issues.Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial ... and determine resolution for manufacturing issues.Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and… more
- LINDT & SPRUNGLI (Stratham, NH)
- …The individual in this position is responsible for running an entire production line, and ensuring line productivity meets department standards for volume and ... meetings. * Verify that lines are supplied with necessary components to meet daily production schedule. * Identify line issues using root cause analysis (5 Why and… more
- Merck & Co. (Rahway, NJ)
- …end-to-end regulatory submission process. The main focus will be on document production processes, including content authoring, review and finalization, and feed to ... be requiredParticipate in System Development Lifecycle (SDLC) documentation review and maintenance of the business standards for account creation and pre-approved… more
- Merck & Co. (Rahway, NJ)
- …work to design, install, and qualify new equipment to support GMP clinical production . Write, review or execute test documents. Limited off shift work may be ... teams.Support establishment of GxP systems in the facility: Change Management, Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP… more
