- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Document Control Lead role is an exempt level position with...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Drive continuous improvement.Have advanced computer… more
- Novo Nordisk Inc. (Boulder, CO)
- …Quality Assurance/ Control , Chemical Development, Program Management, Regulatory, Quality Control , Supply Chain, and Clinical Write, review, and/or ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Quality Compliance Lead as part of the Quality team based in Raritan, ... the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit...team meetings, mentor site users for audit process, and control access to any systems used to support audits/inspections.Provide… more
- Aequor (Waltham, MA)
- …clinical trials Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations. ... and/or 8&plus years of relevant experience Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) Working knowledge and ability to apply… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior ... Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …product release practices.Develop positive relationships with the QA team, Quality Control , Information Technology, maintenance, Manufacturing personnel, ... QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role OverviewThis exempt-level...wide range of activities to support the release of drug products for human use. This position is responsible… more
- Merck & Co. (Durham, NC)
- … substance and drug product, including product inspection, and quality control laboratories.The Specialist, Technical Operations will be responsible for ... of 2 years' experience in pharmaceutical operations, technical services, and/or quality operationsAseptic cGMP manufacturing experience, in biological drug … more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Operations, and other parts of the AR&D organization in aspects of quality control and compliance. Your main responsibilities will include: - ... science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global… more
- Eisai, Inc (Raleigh, NC)
- …Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness, and Quality System Oversight Implementation.Audit and Compliance: Maintain audit readiness, ... support regulatory inspections, manage complaints effectively, oversee change control , review metrics, and conduct annual product reviews. This also involves… more
- Merck & Co. (Rahway, NJ)
- …DescriptionAs part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …industry is required.A Minimum of 2 years relevant work experience.Experience in a Quality Control setting is preferred.Experience with aseptic processing in ISO ... myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Microbiology Data Reviewer is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate has experience working in an aseptic manufacturing facility, preferably in quality control , quality assurance, or cell therapy.Experience in ... is seeking QC Microbiology Technical Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Microbiology Technical Specialist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to communicate the issues and support resolution development.Support IRT design for control of drug dispensing and inventory management. Understand User ... playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside of scope of… more
- Merck & Co. (Rahway, NJ)
- …It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization ... include development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …SOPs, work instructions.Develop positive relationship with the QA team, Quality Control , Information Technology, Maintenance, Manufacturing personnel, Technical ... a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role...status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …position with responsibilities for supervising the operation and workflow of the quality control laboratories in support of cell therapy manufacturing. This ... that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control , quality assurance, or cell therapy. A minimum… more
- Merck & Co. (Rahway, NJ)
- …such as residual and PCR-based assays).Strong background in analytical control strategy development and execution.Demonstrated ability to develop talent through ... in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the ... of the equipment and takes actions to optimize the output, reliability, quality , performance. He/she makes proposals for Continuous improvement and gets to work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …setting with Quality , Manufacturing Operations, Facilities & Engineering Quality Control , Operations Technical Support, Supply Chain and ... outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …finished drug product batches by collaborating with all functions (including Quality Assurance, Quality Control , Operations, Vein to Vein, Batch ... to process improvement initiativesCollaborate with deviation investigation owners and quality leaders to resolve batch release issues and non-conformances in… more
