- Aequor (Aliquippa, PA)
- …management, inbound/outbound coordination, and ERP transaction execution-preferably within GMP , biotech, medical device, or other regulated environments. They ... 3PL. Manage all shipping and receiving documentation, ensuring accurate execution of GMP processes, records, and data entry. Support and execute the on-site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell therapy, testing facility, quality assurance, or manufacturing compliance.Expertise in GMP compliance knowledge including knowledge of 21 CFR Part 11, EU ... and 600, 601, and 610 is preferred.Thorough knowledge and understanding of GMP data integrity standardsKnowledge of cGMP regulations and FDA/EU guidance related to… more
- Merck & Co. (Rahway, NJ)
- …both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, ... Detail-Oriented, Deviation Management, Dispatching, Equipment Qualification, Good Manufacturing Practices ( GMP ), Immunochemistry, Manufacturing, Manufacturing Processes, Microbiology, Molecular Microbiology, Physiology,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …vendor evaluation, and enterprise system interface engineering support for GMP manufacturing of engineered autologous T cell therapy products.Write and/or ... specification review through to testing and implementation in a GMP manufacturing environment.Work cross-functionally across Technical Operations and interface with… more
- Repligen (Waltham, MA)
- …systems (SAP, QMS, PLM, MES, etc.).Ensure technology solutions comply with GMP (Good Manufacturing Processes) and other regulatory requirements.Partner with process ... or managing SAP, QMS, MES, PLM, or similar systems.Expertise in GMP and regulatory requirements in bioprocessing.Experience leading or supporting AI, automation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible to provide process knowledge and expertise in support of GMP investigations, change controls, document control, process improvement, process validation ... RequirementsBS/BA required in technical discipline: Engineering, science or similar field. GMP Manufacturing, Warehouse and Logistics experience in the biotech/biopharma… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Be responsible for the completion of QC testing ... is completed in compliance with all applicable procedures, standards and GMP regulations.Conduct analytical testing of raw material/utility, in-process, or final… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility to support both clinical and commercial requirements in a sterile GMP environment. This role will be responsible for managing change control activities ... relevant regulations and guidances (eg 21 CFR, ICH Q10, EU GDP/ GMP , Part 11/Annex 11, PIC/S, MHRA).Operational experience with electronic quality systems.Familiarity… more
- Cipla (Fall River, MA)
- …is responsible for the creation and revision of new and existing GMP , project handle, qualification & validation documents preparation and execution. In this ... Associate's degree with 4-6 years knowledge and experience of GMP documentation required. Bachelor's degree in science, biochemistry, pharmaceutical engineering,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will serve as the business process owner for the ... 21 CFR parts 210, 211, 1271, 600, 601, 610, ICH Q10, EU GDP/ GMP , Part 11/Annex 11, PIC/S, MHRA).Strong written and verbal communication, analytical problem solving… more
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