- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing to ensure sterility of the product/process is not compromised.Support batch review & material release in SAP for In-house reagents.Support Floor ... prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work in a team based, cross-functional environment to… more
- Tris Pharma (Monmouth Junction, NJ)
- …Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates and maintains various pharmaceutical packaging ... of pharmaceutical products according to SOPs, cGMPs, FDA standards and batch record specifications Performs the day-to-day activities of the packaging process… more
- Twist BioScience (South San Francisco, CA)
- …organized, have the ability to follow established SOPs and complete manufacturing batch records to contribute to the daily production schedule. The ideal candidate ... and/or various intermediates according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule. They will… more
- Aequor (West Greenwich, RI)
- …and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation. Ensure that ... with analytical testing and/or general compendia testing Experience working with batch records and other GMP documentation Knowledge of data integrity requirements… more
- Merck & Co. (Rahway, NJ)
- …Environment (S&E) and GMP requirements as well as ensuring facility readiness for batch processing. In addition, this position is expected to work cooperatively with ... include but are not limited to: Lead, prepare for and/or support batch processing readiness and execution activities. Prepare, review, and/or approve GMP… more
- Aequor (Davie, FL)
- …Manufacturing Practices (cGMP's), and Standard Operating Procedures (SOP's) and Batch Record instructions. Responsible for performing additional related duties as ... to prepare various types of complex high quality technical documentation ( Batch Records (BR), Change Controls (CC), protocols, summary reports, technical… more
- Merck & Co. (Rahway, NJ)
- …independently perform or coordinate routine and specialized audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities ... clinical supplies.- Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or out-of-specification approval,… more
- Aequor (Tampa, FL)
- …wrapping containers. 1-3 Years Experience Summary Execute assembly instructions per Batch Record requirements for Packaging and Labeling processes in compliance with ... the corresponding Room Sanitizations per Departments procedures. Key Accountabilities Follow batch record instructions in the execution of manual process for Primary… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inclusive of Production Planning & Scheduling, Materials Planning, and Batch Logistics, within a personalized cell therapy-manufacturing site. This individual ... will partner with the plant leadership team, various Technical Operations and Quality functions to support both clinical and commercial manufacturing operations, in accordance with cGMP requirements, and company policies & procedures.The position requires… more
- Twist BioScience (South San Francisco, CA)
- …samples for NGS analysis according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule.What You'll Be ... DoingApply Twist's core technologies to develop and optimize commercial kits, kit components, and/or custom products for NGS Target Enrichment, including formulation and protocols.Develop and optimize protocols for commercial kits and/or kit components for NGS… more
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