- Merck & Co. (Millsboro, DE)
- Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that ... molecule manufacturing processes (for biologics and/or vaccines) and sterility assurance requirementsAbility to accurately interpret and apply regulatory expectations… more
- Eisai, Inc (Nutley, NJ)
- …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...predictive analytics to revamp innovation in medicine. Clinical Quality Assurance at Eisai is an independent organization driving end-to-end… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, ... delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality… more
- Insmed Incorporated (San Diego, CA)
- …Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance , the Director of Clinical Quality Assurance (CQA) serves ... use and provides direction, guidance and strategy for company Quality Assurance .Full understanding of and practical experience establishing and fostering compliance… more
- Merck & Co. (Rahway, NJ)
- …performance against forecasts.Collaborate with cross-functional teams, including quality assurance andregulatory affairs, and operations, to aligndata management ... DD&T lab operations.Collaborate across DD&T sub-functions, regulatory affairs, quality assurance , Pharmaceutical Operations, Analytical R&D, and ITa teams to build… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 -supports Person in… more
- Repligen (Waltham, MA)
- …appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality, or related technical ... of experience in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001 audits and supplier quality… more
- Repligen (Waltham, MA)
- …industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product manufacture, test and ... with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules; serve as host for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 issues or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, technical operations or cell ... therapy.Experience with quality support in clinical manufacture is preferred.Flexible to work on weekends, as needed.Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and… more
- Merck & Co. (Rahway, NJ)
- …fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance : Ensure that all activities are conducted with the highest ... regard for safety, quality, and regulatory compliance, aligning with the company's divisional and local site procedures.Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and preparing a variety of crucial decisions that drive both supply assurance , cost savings as well as project executions.The individual manages suppliers from ... contact to contract within a category, leads cross-functional input for decision analysis, and prepares recommendations for senior management.Driving tactical decisions around negotiations with the suppliers will be part of the individual's… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, or cell therapy.Knowledge of cGMP ... and GDP regulations and FDA/EU guidance related to manufacture of cell based productsGreat attention to detail and ability to follow the procedures.The candidate must be highly organized and capable of working in a team environment with a positive attitude… more
- BioAgilytix (Boston, MA)
- …paper and electronic records of test results.Complying with quality assurance procedures, participating in proficiency testing and competency evaluation throughout ... the year.Identifying problems which may adversely affect test performance, troubleshooting test systems and taking appropriate action when appropriate or as directed by Laboratory Management. Including proactively informing Customer Service of any issues which… more
- Merck & Co. (North Wales, PA)
- …stakeholder requirementsPreferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working ... knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverablesExperience assuring programming… more
- Merck & Co. (North Wales, PA)
- …team.Experience in CDISC and ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also required.Must possess broad ... knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness… 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 team and ... with other related business stakeholders. Drive necessary change and efficiency through provision of effective feedback and recommendations.Identify and raise areas of concern where quality gaps have been identified and partner with Medical Affairs leaders to… more
- AUROBINDO (Dayton, OH)
- …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 be able to… more
- Merck & Co. (Rahway, NJ)
- …all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance , regulatory, and manufacturing teams across the CMC ecosystem. Key ... collaborative and influential partnerships span across multiple stakeholders and organizations within our Research and Development (R&D) and Manufacturing divisions.Interface with external suppliers and partners to ensure the quality and compliance of… more
- Tris Pharma (Monmouth Junction, NJ)
- …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 appropriate Corrective Action… more
Related Job Searches:
Audit Assurance Staff Intern,
Food Safety Quality Assurance,
Quality Assurance Analyst,
Quality Assurance Engineer,
Quality Assurance Manager,
Quality Assurance Specialist,
Quality Assurance Supervisor,
Quality Assurance Technician,
Senior Specialist Quality Assurance,
Software Quality Assurance Engineer