- 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 ... responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and… more
- Merck & Co. (Durham, NC)
- …Making, General Safety, Good Manufacturing Practices (GMP), Manufacturing Support, Policy Procedures, Quality Assurance ( QA ), Quality Support, Social ... or other relevant discipline.Minimum of 1 year experience in pharmaceutical operations, technical services, and/or quality operations.Ability to work night shift… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …participation in relevant training programs.Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance.Keep ... state-of-the-art data-driven solutions.Design a fit-for-purpose organization for operational and technical QA oversight.Drive innovative process improvements across… more
- Tris Pharma (Monmouth Junction, NJ)
- …(QMS). Title commensurate with experience.Summary:This position supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product ... and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership,… more
- Merck & Co. (Rahway, NJ)
- …strong relationships with key stakeholders, including research and development, manufacturing, quality assurance , regulatory affairs, and external partners, to ... Job DescriptionThe Executive Director, Device Technical Operations is a pivotal leadership role within the Device Development & Technology (DD&T) organization in our… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and ... chemical engineering, or similar scientific-discipline required with ten (10) years of quality , operational, or technical experience within the GMP regulated… more
- Merck & Co. (Rahway, NJ)
- …of medical devices or medical device combination products with experience in quality assurance or regulatory oversight of these products.Experience authoring, ... list of requirements needed to be specified to supplier ( quality , technical , commercial, supply) - shelf life, critical attributes, essential performance… more
- Aequor (Thousand Oaks, CA)
- …processes involved in quality analytical labs, validation, manufacturing, quality assurance , process development and distribution. 8. Extensive knowledge ... role Summary: Under general direction, functions as the Specialist Quality Control working at the Corporate QC Center. Description:...9. May serve as subject matter expert to develop technical training. 10. May perform routine work in a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....of specialty (deviation management); pharma experience preferred Specific or technical job skills Strong Root Cause Analysis and CAPA… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams… more
- BioAgilytix (Durham, NC)
- …for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory ... LIMS and ERP systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… more
- Merck & Co. (Rahway, NJ)
- …strategic partnerships with manufacturing sites and partner groupsRegulatory Compliance and Quality Assurance :Ensure that all activities are conducted with the ... and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality .Provide Voice of Manufacturing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional ... applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the… more
- Merck & Co. (Rahway, NJ)
- …for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance.Excels in technical writing, able to convert ... and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. The position is a key… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product ... Business Outcomes - Ability to use deep knowledge and expertise in Manufacturing, Technical , and Quality Operations to drive results and business outcomes.… more
- Eisai, Inc (Raleigh, NC)
- …should include a global bio/pharmaceutical background including close collaboration with Quality Assurance , significant interface experiences with the Finance, ... line extensions or site manufacturing changes in collaboration with Product Quality , Regulatory Affairs, and Technical Operations.Establish productive business… more
- Merck & Co. (Rahway, NJ)
- …Final Study Report Maintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed of the study ... and scientific contacts and key opinion leaders in relevant fields.Conduct quality control inspections of study protocol, study documentation files and reports.… 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
- 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 ... is seeking an Automation & Controls Technician (Contractor) as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be… more
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