- Novo Nordisk Inc. (Boulder, CO)
- …timely fashion and in a manner which meets their expectations Acts in role of lead Quality Assurance for NN Boulder Change Control process, including review ... About the Department The Boulder Site is home to the specialized technical operations/CMC...processes at NN Boulder, specifically in the role of Quality Assurance (QA) subject matter expert (SME).This… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …records to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs ... regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality...leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...decisions for QADC collectively with the QADC team.Act as site subject matter expert for "Good Manufacturing Practices" and… more
- Catalent (Philadelphia, PA)
- …in Philadelphia, PA is hiring a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production floor, ... incoming material quality , and/or distribution quality , including quality oversight for material management...support the Supply Chain and Operations department. Act as site subject matter expert for "Good Manufacturing Practices" and… more
- Merck & Co. (Millsboro, DE)
- …all aspects of Operations, Supply, Quality and Business support at the Millsboro site . The Site Digital Technology Lead ensures all project and ... Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global… more
- Insmed Incorporated (Bridgewater, NJ)
- …knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance .Commercial drug manufacturing site QA head experience ... and global company policies & proceduresLead overall management of Quality Assurance programs to support the QC...Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle… more
- Catalent (San Diego, CA)
- Job Title: Quality Assurance Associate, Analytical City: San Diego State : CA JOB DESCRIPTION:Review of analytical release and stability data, involving review ... Lead role in onboarding new compounds to the site involving review of toxicology data and performing a...equipment.Point person for safety complaints and improvements in the Quality Assurance Department using the Intelex software… more
- Merck & Co. (Durham, NC)
- …in state of control based on Sterility Assurance requirements ensuring an integral process.- Lead a Quality team to provide QA support to assigned areas of ... Job DescriptionOur Teknika Quality Assurance group ensures every single material inside our products is manufactured, tested, and distributed in alignment with… more
- Merck & Co. (Durham, NC)
- …data. This role requires close collaboration with various teams including Production, Quality Assurance , Validation and Facilities, as well as external ... improvements, report writing, involvement in interdepartmental committees and projectsInitiate and lead Change Requests utilizing IPIParticipate in Quality Risk… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … and complaint product supply. Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the CAR-T manufacturing site . Oversee metrics, trending, and reporting of relevant quality systems records. Implement and lead CAPA site governance ... the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Merck & Co. (Rahway, NJ)
- …to engage key stakeholders also required.Must possess demonstrated success in the assurance of deliverable quality and process compliance; and strong working ... and is accountable to set strategy for the delivery of high quality and compliant statistical analysis and reporting.Direct the activities of programmers whose… more
- Insmed Incorporated (Bridgewater, NJ)
- …substance sections of regulatory filings and dossiers.Sound awareness of Regulatory, Quality Assurance , and cGMP requirementsHigh energy, innovative "can do" ... for being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …completion of batch release related impact assessments. Support compliance activities for site Quality Operations in accordance with Legend standards, procedures ... must have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate hasexperience working in an aseptic manufacturing facility, preferably in quality assurance ,manufacturing compliance, clinical quality , or cell ... multiple myeloma. Legend Biotech is seeking QA Shop Floor Supervisor as part of the Quality team based in Raritan, NJ. Role Overview The QA Shop Floor Supervisor is… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support, including Service delivery and Incident response) IT Infrastructure SME for Quality assurance / GMP and Validation: Maintain qualified state of ... About the Department Site New Hampshire, located in West Lebanon, is...to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …across functional teams consisting of internal customers such as Project Management, Site Operations, Validation, and Quality Assurance to properly ... crucial in the execution of all Engineering related activities carried out on- site , including but not limited to automation, process, capital projects, and equipment… more
- Catalent (San Diego, CA)
- …and compliance.Collaborate with other departments to troubleshoot technical issues.Collaborate with Quality Assurance and Quality Control on analytical ... studies to determine if methods are suitable for transfer to Quality Control.Communicate results both internally and externally through oral and written… more
- Olsson (Lincoln, NE)
- …daily commissioning processes and perform pre functional and functional testing. Will lead efforts to secure repeat client work, may support marketing and business ... + Strong Knowledge base of Pre Functional and Functional Commissioning + Ability to lead projects and self-starter to take on a variety of tasks to best serve… more
- Astrix Technology (Buffalo, NY)
- …+ Added - 30/04/2024 Apply for Job **Responsibilities:** + Serve as the site lead of quality assurance and the management representative of large scale ... Quality Assurance Manager Quality Assurance...continuously improve the quality management system at the site level. + Provide site quality … more
