- Novo Nordisk Inc. (West Lebanon, IN)
- …realize your potential? The Position This position has primary responsibility to support Quality Control (QC) operations in the microbiology or analytical area. ... to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries out routine QC testing… more
- Merck & Co. (North Wales, PA)
- …and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools.Knowledge and ... It is business critical that our company receives consistent, accurate, high- quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation… more
- Novo Nordisk Inc. (Boulder, CO)
- …Chemical Development, Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance. The Technical Team Lead , API Manufacturing ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to global Development governance. In this key role, the candidate will have to lead a complex, global team in charge of a global clinical program designed to ... the GTL has accountability that far exceeds its direct span of control which require very strong cross-functional leadership abilities. The role reports to… more
- Merck & Co. (Durham, NC)
- …provides the best in class services with the final goal of delivering our high- quality vaccines to the patients around the world.With our core principle of Safety ... First and Quality Always EMSS strives to have the safest and...customer service-oriented leader to support the Teknika IPT. Will lead the tactical and strategic equipment reliability improvements, human… more
- Merck & Co. (Rahway, NJ)
- …department, within function and cross-functionally.Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial ... Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in ... Raritan, New Jersey. Role Overview The Lead QC Microbiology Data Reviewer is an exempt level...relevant QC documents, logbooks, SOP's and WI's. Ensure microbiological control strategy is consistent with cGMP requirements. Participate in… more
- Merck & Co. (Rahway, NJ)
- …state business objectives. Within the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all areas of SAP Technology.-They ... Middleware/Integration and Reporting/Analytics standards, patterns, and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology… more
- Catalent (San Diego, CA)
- …compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Lead the development of site Quality Objectives, site Quality ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA... issues to Site Leadership Team and QA senior management. Lead programs for: QA department budget, Site Training, Supplier… more
- Catalent (Harman, WV)
- …biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/ Quality Control function with a strong familiarity ... independently under minimum supervisionAbility to work in fast paced environment supporting the quality assurance/ quality control departments of a CMO for… more
- Catalent (Harman, WV)
- …First culture at the site. The Head of Quality -Maryland is responsible for Quality , Validation and Quality Control and is the most responsible person ... Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures is performed on manufactured products.Review and… more
- Catalent (Manassas, VA)
- … Quality Foods (SQF) Certification, and its initiatives. This position also requires Quality Control data base management and control over product ... formulation and analytical services to solve difficult development and manufacturing challenges.The Quality Assurance Supervisor will lead Food Safety and … more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior ... Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency projects, ... years relevant experience requiredExtensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the ... and respective CROs in order to ensure high data quality and proactive detection and resolution of issues. Lead...control and ensure required compliance levels. Implement and lead the process to regularly review and assess KQIs… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …manage the departments of Quality Assurance, Sterility Assurance, and Quality Control .Experience Requirements 15+ years of relevant and current work ... Design and implement programs, policies, and practices to ensure Quality Assurance and GxP compliance, and lead ...ensure Quality Assurance and GxP compliance, and lead a quality culture within the organization.Ensure… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The Lab Senior… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …major equipment, important systems, instrumentation, and computerized systems.Knowledge of quality systems including exception management, change control , ... of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, USP, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Therapy Manufacturing Plant. In addition, the candidate must have Quality Risk Assessment experience in the pharmaceutical industry.Primary responsibilities include, ... Assessment plans with milestones and deliverables in collaboration with stakeholders ( Quality , production, engineering, QC and process improvement and R&D etc.);… more
