- Merck & Co. (Rahway, NJ)
- Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program. In this ... manufacturing excellence from development through commercialization. You'll partner across Quality , Regulatory, Technical, and Supply Chain teams-coaching, facilitating, and… more
- Formation Bio (New York, NY)
- …efficiently.About the PositionWe are seeking a highly accomplished, strategic Vice President of Quality Assurance . In this pivotal role, you will have the ... to establish the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of ... risks is recognized and the need for CAPAs or reports on deviations is clearly understood. Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the need to address such… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role OverviewThe Head...OverviewThe Head of Compliance will be responsible for providing quality oversight over the compliance program within the global… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …must have experience working within an aseptic manufacturing facility, preferably within quality control, quality assurance , training/systems applications, ... myeloma.Legend Biotech is seeking QC Technical Trainer III as part of the Quality team based in Raritan, NJ.Role OverviewThe QC Technical Trainer is an exempt… more
- Merck & Co. (Rahway, NJ)
- …with partners in other functional lines, such as Drug Safety and Metabolism, Quality Assurance , and program management, under the supervision of management ... samples, setting up instrument analysis, and processing and interpreting LC-MS/MS data; Assurance that notebooks and other documentations are up-to-date as per GLP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate has experience working in a cGMP manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... QA Change Control Specialist II as part of the Quality team based in Raritan, NJ.Role OverviewThe QA Change...is an exempt level position with responsibilities for providing quality oversight over the change control process within a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... a QA Validation Specialist III as part of the Quality team based in Raritan, NJ.Role OverviewThe QA Validation...is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , technical ... QA Shop Floor Specialist III as part of the Quality Operations team based in Raritan, New Jersey. Role...is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … systems and cGMP requirements.Work in a collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing Operations, ... is seeking QC Analyst I as part of the Quality team based in Raritan, NJ. Role OverviewThe QC...a biological and/or pharmaceutical industry is required.Experience in a Quality Control setting is preferred.Experience with processing samples in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...Role OverviewThe QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell… more
- Formation Bio (New York, NY)
- …Partner with other CMC groups (analytical development, supply chain, etc) quality assurance , regulatory, clinical pharmacology and project management to ... drug product vendors, for both development and manufacturing, ensuring high- quality deliverables and compliance with GMP and regulatory standards. Documentation:… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality systems and cGMPrequirements.Works in a collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing ... myeloma.Legend Biotech is seeking QC Investigations Specialist II as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Investigations Specialist is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations 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)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance.Expertise in GMP compliance ... knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among othersExperience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.Thorough knowledge and understanding of GMP data integrity standardsKnowledge of cGMP… more
- Merck & Co. (Rahway, NJ)
- …of spend.- Sourcing Management: Uses the Sourcing Management Process to manage assurance of supply, quality , service, cost, innovation and regulatory compliance ... relationships with key leaders and stakeholders, namely External Manufacturing, Quality /Regulatory, Finance, Legal, and Shared Business Services, and other corporate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. We are currently seeking a Global DX Project Assurance Intern from June 2026 - May 2027. This position will be full-time (37.5 ... PPM systems and processes.- Apply AI tools to automate and improve portfolio data quality .- Onboard new projects and teams to PPM systems.- Assist with PPM training… more
- Merck & Co. (Rahway, NJ)
- …for R&D projects (data, analyses, tables, graphics, listings)Demonstrated success in the assurance of deliverable quality and process compliance. Good working ... knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)Ability to comprehend data analysis plans which may describe observational research and statistical methodology to be programmed and turn into actionable code; understanding and… more
