- Legend Biotech USA, Inc. (Raritan, NJ)
- …members.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Review change controls , SOPs, and other ... Part 11/Annex 11, PIC/S, MHRA).Operational experience with electronic quality systems .Familiarity with core Quality Management System processes.Strong written… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Document Control Specialist as part of the Quality team based in Raritan, NJ.Role ... OverviewThe QA Document Control Specialist role is an exempt level position with...This role will ensure compliance within the document management system , document storage and retention, and document issuance and… more
- Insmed Incorporated (NJ)
- …Are:You have a Bachelor's degree along with 2+ years of experience ona document control team using a quality management system , with preference to Veeva.You are ... Are you?About the Role:We're looking for a Quality Management System (QMS) Specialist on the Analytical Development team to...based on trend analysis of CAPAs, deviations and change controls .Serve as a key audit contact point by assisting… more
- Twist BioScience (South San Francisco, CA)
- …Writer - Temporary is responsible for directly participating in a Quality Systems Integration Program, with primary responsibility being the creating of high-quality ... Quality Assurance, Regulatory Affairs, Supplier Quality, Supply Chain, Quality Control , Production, Process Development, Product Development, Software Development, R&D,… more
- Insmed Incorporated (San Diego, CA)
- …of science, we're in. Are you?About the Role:We're looking for a Manager, Quality Control - Biological Assayas on the Research team to help us expand what's possible ... on a CMC team.Perform quality management activities such as deviation, CAPA, change control , investigation of OOS, OOT and anomalous results within the company QMS… more
- Aequor (Thousand Oaks, CA)
- …collaborative attitude to the team. Comfortable with basic computer skills and documentation systems . Familiarity with GMP principles is a plus, but not a strict ... routine laboratory testing and related activities in support of Quality Control operations. The role requires adherence to current Good Manufacturing Practices… more
- Aequor (Athens, GA)
- …operating procedures to conduct environmental monitoring activities. Use data management systems to enter and track results. Demonstrate a visible & tangible ... techniques Experience with aseptic techniques, clean room operations, or microbial control . Ability to meet standards for aseptic gowning qualification Demonstrated… more
- Insmed Incorporated (NJ)
- … controls , periodic reviews, and revalidation efforts throughout the system lifecycle.Evaluate and manage third-party vendors and SaaS/cloud-based clinical ... future of science, we're in. Are you?About the Role:We're looking for a GxP Clinical Systems IT Owner in the IT team to help us expand what's possible for patients… more
- Repligen (Waltham, MA)
- …Change Management, System Operations, and IT Governance.Conduct IT application control reviews for key systems (eg, SAP, Tagetik, Workday, ... remediation plans for identified control weaknesses.Serve as SME for system implementations and infrastructure changes to ensure " controls by… more
- Merck & Co. (Rahway, NJ)
- …responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept ... for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes… more
- Cipla (Fall River, MA)
- …to maintain GMP Participate in the internal and external audits to assure system control Review new batch manufacturing records, SOPs, APQR for correctness ... documentation for audit readiness Handle investigations, OOS, OOT, change controls , deviation & CAPA in the block Ensure online...because of limited budget. Overcome by maintaining the centralised control system for minimum stock of spare… more
- Merck & Co. (Durham, NC)
- …priorities - schedule & cost, installation).Extensive industrial experience involving utility system generation, distribution and controls are needed. Engineer ... This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations… more
- Aequor (Hicksville, OH)
- …Supports and assists in the installation and qualification of new equipment and controls ; supports facilities systems and services as required. Develops low to ... and other data in non-network process equipment. Backup of electronic records, system files, and operating systems . Assist with review, investigation and… more
- Merck & Co. (Rahway, NJ)
- …Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems .Lead integration of control systems with MES, Quality, ... to meet project, operations, and qualification needs.Execute and develop appropriate system validation, change control , and testing documentation in partnership… more
- Merck & Co. (Durham, NC)
- …- schedule & cost, installation). Extensive industrial experience involving utility system generation, distribution and controls are needed. Engineer must ... CMMS experience related to plant maintenance and spare parts procurement systems Project management, including change control and equipment qualification… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …position will be responsible for providing engineering support for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy ... management, issues, deviations, corrections, remediation and improvement efforts of automation and controls systems for facility, equipment, systems and… more
- Cipla (Fall River, MA)
- …preferred. Basic understanding of mechanical machinery and the operating principles of control systems . Ability to follow both verbal and written instructions. ... Operations, and Facilities Operations.Job Description: The Warehouse Coordinatormonitors and controls the production demand for raw material, packing material and… more
- Aequor (Fort Worth, TX)
- …and carries out engineering project work with minimal direction. Troubleshoots equipment/process control systems and change control activities. Programs ... Description: High-Speed Packaging experience Controls Background No specific education requirements 5-10 years...systems while ensuring safety, and validating the automated system for alignment to requirements, CGMPs, and intended … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …. Investigate, troubleshoot, and provide repairs to equipment, instruments, instrumentation systems , electrical systems , controls , motors with voltages ... OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on… more
- Twist BioScience (South San Francisco, CA)
- …software for laboratory instruments, interface with our Manufacturing Execution System (MES), and implement tools to streamline manufacturing workflows. This ... lab instrumentation and a passion for building reliable, scalable systems that empower high-throughput biotech manufacturing. Key Responsibilities:Design, implement,… more
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