30 quality assurance technician jobs found

Biogen Biogen's Decision & Quality Analytics Innovation (DQAI) team is part of Portfolio Leadership, Analytics & Insights (PLAI), which is under the Development department. The vision of the DQAI team is to deliver trusted insights that drive smarter decisions and measurable impact across the research, development and medical (RDM). We are seeking an experienced and highly motivated Associate Director of Data Management & Stewardship to join our team. This individual will take ownership of managing all aspects of our team's data - from acquisition and stewardship to governance and cross-functional alignment. The role will ensure that our data foundation is robust, well-governed, and positioned to enable advanced analytics, including AI/ML, simulation, etc. and ultimately support critical portfolio decision-making. Key Responsibilities Own the Data Foundation Manage the full lifecycle of portfolio and analytics data across research, development, and...

Merck Job Description The Executive Director, US Data Strategy is responsible for ensuring Human Health (HH) has an industryleading strategy and approach to sourcing, creating, and activating commercial data assets that inform businesscritical decisions and actions across US business units (Oncology, Vaccines, Pharma, Respiratory, Rare Disease). The leader will create, own, and implement the HH US data asset strategy and innovation agenda across commercial data domains (HCP, consumer, payer, patient, account, engagement, and related sources). The role maximizes the return on HH's substantial annual investment in thirdparty data and unlocks value from firstparty, unstructured data assets while ensuring compliance with applicable US privacy and regulatory requirements. Position Responsibilities: Treat data as a strategic asset to empower the organization to drive innovation, make informed decisions, and create competitive advantage for Human Health (HH) US. Shapes...

Merck Job Description The Executive Director, US Data Strategy is responsible for ensuring Human Health (HH) has an industryleading strategy and approach to sourcing, creating, and activating commercial data assets that inform businesscritical decisions and actions across US business units (Oncology, Vaccines, Pharma, Respiratory, Rare Disease). The leader will create, own, and implement the HH US data asset strategy and innovation agenda across commercial data domains (HCP, consumer, payer, patient, account, engagement, and related sources). The role maximizes the return on HH's substantial annual investment in thirdparty data and unlocks value from firstparty, unstructured data assets while ensuring compliance with applicable US privacy and regulatory requirements. Position Responsibilities: Treat data as a strategic asset to empower the organization to drive innovation, make informed decisions, and create competitive advantage for Human Health (HH) US. Shapes...

Merck Job Description Role Overview The value team in Research and Development IT team brings together product management, engineering, and data science expertise to enable data and technology products and services that accelerate our scientists' ability to discover and develop innovative medicines that change the course of human health. Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation and advance the drug discovery and development pipeline. We are seeking a highly skilled Software Engineer to join our team, focusing on enhancing sample management capabilities within the pharmaceutical domain. The ideal candidate will possess a skill set that encompasses technical expertise, domain-specific knowledge, team leadership and strong people skills to effectively...

Merck Job Description Role Overview The value team in Research and Development IT team brings together product management, engineering, and data science expertise to enable data and technology products and services that accelerate our scientists' ability to discover and develop innovative medicines that change the course of human health. Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation and advance the drug discovery and development pipeline. We are seeking a highly skilled Software Engineer to join our team, focusing on enhancing sample management capabilities within the pharmaceutical domain. The ideal candidate will possess a skill set that encompasses technical expertise, domain-specific knowledge, team leadership and strong people skills to effectively...

Merck Job Description The Senior Specialist, Business / Technology Analysis supports highimpact initiatives within Integrated Account Management (IAM) and US Vaccines Analytics for our Company's Global Human Health US Market. This role is business and technology delivery focused, translating business needs into implementable technology solutions and partnering closely with delivery teams to drive execution. Operating at the Senior Specialist (P3) level, this role requires independent ownership, strong analytical rigor, and the ability to influence outcomes across business, IT, and vendor teams while delivering reliable, measurable value. Key Responsibilities Design and deliver technology solutions that support contracting, sales, and analytics outcomes across IAM and US Vaccines. Translate business needs into clear technical requirements, functional specifications, and implementationready user stories with acceptance criteria. Perform data analysis to identify...

Merck Job Description Role Overview The value team in Research and Development IT team brings together product management, engineering, and data science expertise to enable data and technology products and services that accelerate our scientists' ability to discover and develop innovative medicines that change the course of human health. Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation and advance the drug discovery and development pipeline. We are seeking a highly skilled Software Engineer to join our team, focusing on enhancing sample management capabilities within the pharmaceutical domain. The ideal candidate will possess a skill set that encompasses technical expertise, domain-specific knowledge, team leadership and strong people skills to effectively...

Merck Job Description Role Overview The value team in Research and Development IT team brings together product management, engineering, and data science expertise to enable data and technology products and services that accelerate our scientists' ability to discover and develop innovative medicines that change the course of human health. Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation and advance the drug discovery and development pipeline. We are seeking a highly skilled Software Engineer to join our team, focusing on enhancing sample management capabilities within the pharmaceutical domain. The ideal candidate will possess a skill set that encompasses technical expertise, domain-specific knowledge, team leadership and strong people skills to effectively...

Merck Job Description The Senior Specialist, Business / Technology Analysis supports highimpact initiatives within Integrated Account Management (IAM) and US Vaccines Analytics for our Company's Global Human Health US Market. This role is business and technology delivery focused, translating business needs into implementable technology solutions and partnering closely with delivery teams to drive execution. Operating at the Senior Specialist (P3) level, this role requires independent ownership, strong analytical rigor, and the ability to influence outcomes across business, IT, and vendor teams while delivering reliable, measurable value. Key Responsibilities Design and deliver technology solutions that support contracting, sales, and analytics outcomes across IAM and US Vaccines. Translate business needs into clear technical requirements, functional specifications, and implementationready user stories with acceptance criteria. Perform data analysis to identify...

Merck Job Description The Executive Director, US Data Strategy is responsible for ensuring Human Health (HH) has an industryleading strategy and approach to sourcing, creating, and activating commercial data assets that inform businesscritical decisions and actions across US business units (Oncology, Vaccines, Pharma, Respiratory, Rare Disease). The leader will create, own, and implement the HH US data asset strategy and innovation agenda across commercial data domains (HCP, consumer, payer, patient, account, engagement, and related sources). The role maximizes the return on HH's substantial annual investment in thirdparty data and unlocks value from firstparty, unstructured data assets while ensuring compliance with applicable US privacy and regulatory requirements. Position Responsibilities: Treat data as a strategic asset to empower the organization to drive innovation, make informed decisions, and create competitive advantage for Human Health (HH) US. Shapes...

Merck Job Description The Executive Director, US Data Strategy is responsible for ensuring Human Health (HH) has an industryleading strategy and approach to sourcing, creating, and activating commercial data assets that inform businesscritical decisions and actions across US business units (Oncology, Vaccines, Pharma, Respiratory, Rare Disease). The leader will create, own, and implement the HH US data asset strategy and innovation agenda across commercial data domains (HCP, consumer, payer, patient, account, engagement, and related sources). The role maximizes the return on HH's substantial annual investment in thirdparty data and unlocks value from firstparty, unstructured data assets while ensuring compliance with applicable US privacy and regulatory requirements. Position Responsibilities: Treat data as a strategic asset to empower the organization to drive innovation, make informed decisions, and create competitive advantage for Human Health (HH) US. Shapes...

Biogen About This Role This role is part of the Clinical Trial Accelerator Unit (CTAU) and is responsible for accelerating Study Start Up activities and ensuring all site activations are made on time in global clinical studies. The individual will harmonize processes and provide start-up expertise to assigned studies and programs, ensuring study teams meet or exceed Final Protocol to First Patient In timelines. The role involves direction and execution, quality compliance, risk management, performance monitoring and cross-functional collaboration. What You'll Do Lead and oversee the execution of site activation for global clinical studies Develop and maintain critical path and timelines for site activation Oversee and negotiate timelines for Master Informed Consent Forms (ICFs), including country and site-level ICF creation. Ensure site activation activities are inspection-ready and compliant with ICH-GCP and Biogen SOPs Perform or delegate quality checks on...

Merck Job Description Digital is the multiplier that will allow Development Sciences and Clinical Supply (DSCS) to deliver better experiments faster, efficient filing and launch, more robust supply chains and higher-confidence decisions across the portfolio. The DSCS Digital Technologies organization is tasked with the mission to pioneer and deploy innovative digital technologies that drive the acquisition, automation and utilization of data to enhance insights, efficiency, and quality of DSCS processes and methods. The Executive Director of Digital Insights will lead multidisciplinary digital teams focused on building robust data pipelines, developing advanced data visualizations, and delivering in silico tools and predictive science solutions. The leader will help drive the digital transformation of R&D and manufacturing processes inclusive of drug substance, drug product and analytical efforts and all therapeutic modalities, ensuring seamless integration of...

Merck Job Description Digital is the multiplier that will allow Development Sciences and Clinical Supply (DSCS) to deliver better experiments faster, efficient filing and launch, more robust supply chains and higher-confidence decisions across the portfolio. The DSCS Digital Technologies organization is tasked with the mission to pioneer and deploy innovative digital technologies that drive the acquisition, automation and utilization of data to enhance insights, efficiency, and quality of DSCS processes and methods. The Executive Director of Digital Insights will lead multidisciplinary digital teams focused on building robust data pipelines, developing advanced data visualizations, and delivering in silico tools and predictive science solutions. The leader will help drive the digital transformation of R&D and manufacturing processes inclusive of drug substance, drug product and analytical efforts and all therapeutic modalities, ensuring seamless integration of...

Merck Job Description The Clinical Services scientist position under the guidance of a West Point laboratory animal resources husbandry operations, works to provide world class animal care to impact drug development and discovery and improve human health. With minimal direction and in compliance with departmental Standard Operating Procedures, our Research & Development Division study requirements, as well as applicable regulations and guidelines to include USDA regs, NIH Guide and, Good Laboratory Practices, this position oversees the details of animal care and related activities of Laboratory Animal Resources, to include indirect guidance of animal care workers. Has responsibility to assist with the training, development, assignment coordination and safety of hourly personnel. Contributes to making work assignments, ensuring completion and quality, and administers personnel policies. Ensures that quality support of research laboratory animal programs is a team...

Biogen About This Role The Director of SABR Submissions Sciences is responsible for leading Global Delivery Management (GDM) function: This role is globally accountable for the operational leadership of GDM function. GDM function delivers timely and quality submissions to global regulatory authorities for both major submissions and Lifecycle management. This role provides strategic leadership, optimizes resource allocation, develops initiatives, and drives operational excellence for entire GDM function. Cross functional collaboration and building trusted relationships (with Regulatory, Reg CMC, Portfolio Management etc) Leads the planning, preparation, and submission of regulatory documents (e.g., eCTD, IND, NDA) to health authorities, ensuring compliance and strategic alignment. Determines Submission Sciences support model and resource allocation. Supports IT initiatives including acquisitions, divestitures, software upgrades, and new software solutions Develop and...

Biogen This onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed About This Role We are seeking a highly experienced and motivated Biochemistry Senior Associate II to join the Biochemistry team at our RTP biologics drug substance manufacturing facility. The role will support advancing biochemistry laboratory activities, including method execution, troubleshooting, instrument validation, data interpretation, and participation in project teams. This role primarily works independently with minimal supervision as needed, consults with management on key decisions. What You'll Do Act as the primary team lead and represent the team in absence of Manager Conduct laboratory investigations (i.e. invalids, OOS, and atypical) and deviations Reviews tests, approves release data, and issues certificates Authors and review protocols, change control requests, and SOPs Serve as a technical resource for the workgroup or project...

Biogen Schedule: This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours. About This Role We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this role is responsible for method qualification and projects as assigned. What You'll Do Review test data in LIMS Prepare quarterly EM/UM reports Supports testing for all qualification and study directed testing Troubleshoot complex assays Perform microbiology testing...

Biogen About this role The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs.You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is...

Biogen About This Role As a Principal Application Specialist, you will play a critical role in designing, building, implementing, and maintaining Veeva Vault Document Management System. Biogen is undergoing a business transformation with technology as a core enabler. Veeva Vault QualityDocs is a critical component of this transformation, and you will be the ultimate driver, leveraging your expertise to ensure high-quality service delivery, optimal system performance, and seamless user experiences. Acting as the IT System Owner for Veeva Vault QualityDocs, you will collaborate closely with cross-functional teams, including business analysts, technical architects, system configurators and project managers, to deliver upgrades, enhancements, new modules, and other initiatives aligned with strategic business roadmaps. Your work will directly support Biogen's Employee Experience and GxP compliance, ensuring that our document management system meets regulatory requirements and user...