- iconectiv (Bridgewater, NJ)
- …memos, reports, and correspondences + Experience with reporting, metrics, SLA management, and quality assurance + Strong organizational skills and the ability to ... build effective working relationships + Excellent work ethics and customer focus + Initiative, critical thinking and good follow through are key characteristics + Any experience with Service Now or Jira or similar ticketing system is a must + ITIL… more
- 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
- 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)
- …pharmacopeia while remaining current in on-the-job training requirements.Collaborate with Quality Assurance , Manufacturing, Technical Operations, Engineering and ... will be assigned, as necessary.Works in a collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing Operations,… 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)
- …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
- 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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs ... Affairs QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing… 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
- 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)
- …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
- Terumo Medical Corporation (Somerset, NJ)
- …nursing, or related field required and minimum 5 years of experience in clinical quality assurance or clinical quality operations or a combination of ... Sr. Clinical Quality Specialist Date: Oct 21, 2025 Req ID:...develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of… more
- Terumo Medical Corporation (Somerset, NJ)
- …education, background, and experience. 3. Experience in a medical device quality assurance environment preferred 4. Regulatory Affairs Certification preferred. ... develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of...drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of… more
- Terumo Medical Corporation (Somerset, NJ)
- …forwarding of customer complaints (ie adverse events, product performance reports, etc.) to Quality Assurance (QA), and by ensuring all promotional messaging (ie ... develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of...drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of… more
