- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist III as part of the Quality team based in Raritan, ... Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment,… more
- Merck & Co. (Rahway, NJ)
- …in medical device engineering, particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination ... set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for Cell/Gene ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and ... and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, including… more
- Merck & Co. (Durham, NC)
- …The selected candidate will participate in equipment validation , process validation , and GMP laboratory readiness.- The Quality Operations Laboratory ... product, and laboratory testing for the BCG vaccine.The Specialist, Quality Control participates in a team of analysts in...participates in a team of analysts in the development, validation , and routine testing for the BCG Product. The… more
- Eisai, Inc (Exton, PA)
- …Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control, Validation , and ... suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting… more
- Twist BioScience (South San Francisco, CA)
- …analytics, and data visualization capabilities to support operational decision-making and quality reviews.Compliance & Validation : Ensure our custom MES ... quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols and documentation, specifically… more
- Katalyst HealthCares and Life Sciences (Summit, NJ)
- Responsibilities: Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities. This role ... Clean Rooms. Employee will be required to work closely with Manufacturing, Validation , Site Automation, Engineer, Quality Control, and Global Technical… more
- Merck & Co. (Rahway, NJ)
- … Validation Specialist will work as part of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across ... Job DescriptionTitle: Specialist, Metrology and Validation , Analytical Research & DevelopmentJob Description-The Analytical Research & Development (AR&D) External… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization. This ... position ensures that all global systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best… more
- Merck & Co. (Rahway, NJ)
- …controls, risk analysis, control strategies, design verification testing, and process validation , with a strong understanding of quality management systems ... launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project… more
- Merck & Co. (Rahway, NJ)
- …and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment are ... GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.- Prepare and… more
- Aequor (Swiftwater, MN)
- …This position supports the execution of routine testing in the Quality Control Analytical Chemistry laboratory, including chemistry assays associated with Incoming ... Quality and Raw Materials. This position requires proficiency and...laboratory management to meet demands of Production, Method Development, Validation , Independent Demand, and Stability program. Maintain safety and… more
- Aequor (Cincinnati, OH)
- Quality Control Analyst I Does the position allow for the worker to be virtual/remote? No Temp to Perm: Temp to perm based on openings and performance Shift ... Perform routine and non-routine physical and chemical testing of commercial, validation and stability samples in accordance to written methodology Analyze data… more
- Eisai, Inc (Nutley, NJ)
- …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 oversight of the … more
- Formation Bio (New York, NY)
- …that adheres to CI/CD and data governance best practices. Implement data validation and observability frameworks to ensure quality , trust, and reproducibility ... infrastructure, and generative AI. While your initial focus will be on building high- quality EHR models for Formation Bio platform, you'll also contribute to our… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …your potential? The Position This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. This ... to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries out routine QC testing… more
- BioAgilytix (San Diego, CA)
- …infrastructure.Essential ResponsibilitiesParticipates in implementation planning, qualification and/or validation of laboratory systems and softwareAuthors and ... etc.) Contributes to the development and revision of Computer System Validation procedures and policies (validations, change control, data integrity), following 21… more
