- Merck & Co. (Millsboro, DE)
- Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites ... GMP Compliance, Manufacturing, Pharmaceutical Quality Control (QC), Preventive Action, Quality Assurance (QA), Quality Assurance Auditing, Quality… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for design, delivery and execution ... of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality management… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is ... for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of… more
- Insmed Incorporated (San Diego, CA)
- …Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance , the Director of Clinical Quality ... for potential use and provides direction, guidance and strategy for company Quality Assurance .Full understanding of and practical experience establishing and… more
- Repligen (Waltham, MA)
- …issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality ... 5+ years of experience in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001 audits and supplier … more
- Repligen (Waltham, MA)
- …the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product ... meetings with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules; serve… 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
- Merck & Co. (Rahway, NJ)
- …and tracking performance against forecasts.Collaborate with cross-functional teams, including quality assurance andregulatory affairs, and operations, to ... and benefits DD&T lab operations.Collaborate across DD&T sub-functions, regulatory affairs, quality assurance , Pharmaceutical Operations, Analytical R&D, and ITa… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.Vendor Management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , technical ... a QA Shop Floor Specialist 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 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
- 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
- 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 Validation Specialist I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and clinical project management competencies within Clinical OperationsWork in collaboration with Quality Management and Quality Assurance to develop and ... studies are conducted according to the timeline, budget and quality measures set forth by the Study teams. This...as our Network sites) and drive the CRO to quality , cost, and shortened timelines wherever possible. The ED… more
- Merck & Co. (Rahway, NJ)
- …members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance : Ensure that all activities are conducted with ... launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities: Strategic Leadership and… more
- BioAgilytix (Boston, MA)
- …procedures. Maintaining paper and electronic records of test results.Complying with quality assurance procedures, participating in proficiency testing and ... established turnaround times.Analyzing, reviewing, approving, and reporting test and quality control results according to established acceptance criteria and… more
- AUROBINDO (Dayton, OH)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewTo perform this job successfully, an individual must… more
- Merck & Co. (Rahway, NJ)
- …advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance , regulatory, and manufacturing teams across the CMC ... Manufacturing divisions.Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving performance,… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, ... including reviews/approvals of Change Control Reports (CCRs), methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management, conducts laboratory investigations and recommends… more
- Formation Bio (New York, NY)
- …obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor ... compliance with company policies, industry regulations (eg, FDA, EMA, GxP), and data security requirements. Identify opportunities for cost savings, contract optimizations, and risk mitigation. Implement procurement analytics and reporting tools to provide… more
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