- Aequor (Washington, DC)
- …- Fri 9 AM - 1 PM EST SCOPE OF RESPONSIBILITIES: accountable for supporting regulatory policy efforts within the Regulatory Science and Policy team will be at ... ambiguity to drive decision-making working across teams DUTIES: Work with regulatory leads through cross-functional team support on both strategic and tactical… more
- Merck & Co. (Durham, NC)
- …management program.Provides active support during audits and inspections ( regulatory , internal, safety), as required.Executes raw material sampling and inspection ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- Merck & Co. (Durham, NC)
- …seeking a Growth and Improvement minded Quality Control Laboratory Associate Specialist that can help drive our Strategic Operating Priorities.Invent-- Pursue the ... product and support laboratory testing for vaccines.The Quality Control Laboratory Associate Specialist participates on a team of analysts in the method transfer,… more
- Merck & Co. (Durham, NC)
- …vaccines in the Global Vaccine and Sterile Manufacturing organization.The successful Specialist candidate will be energetic and technically sound, with strong ... these programs.Author, review, and/or edit validation documents to support regulatory filingsSupport Change Control documentation for complex process, validation,… more
- Merck & Co. (Durham, NC)
- …medicines and vaccines, including our HPV vaccines. - The Senior Engineering Specialist will troubleshoot and maintain process and process support equipment utilized ... of work performed. Executes SAP transactions including spare parts management and PM change control. Monitors calibration, maintenance, and equipment/utilities… more
- Merck & Co. (North Wales, PA)
- … management (data collection, processing, storage, and retrieval) and worldwide regulatory data management and reporting requirements.Strong knowledge of the ... library componentsParticipates in standards data governance reviewsThe GCDS Data Standards Specialist may contribute to the definition and maintenance of business… more
- Merck & Co. (Durham, NC)
- Job Description Position Description: The Quality Operations Laboratory Associate Specialist performs laboratory testing on a variety of routine waters, product ... lab scheduling, have a strong understand of Labware Laboratory Information Management System (LIMS), support water, bioburden and endotoxin testing. Primary… more
- Aequor (Bothell, WA)
- …cross-functional experience, strong interpersonal skills *Job Description: The Quality Assurance Specialist position plays a key role in supporting the cGMP quality ... presence within a regulated cGMP environment. The primary focus of the QA Specialist role will be to support routine clinical and commercial production to ensure… more
- Aequor (Seattle, WA)
- …project management skills. Experience interacting with FDA or other regulatory agencies strongly preferred. Strong knowledge of cGMPs and domestic regulatory ... cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client… more
- Merck & Co. (Durham, NC)
- …of work performed.Executes SAP transactions including spare parts management and change control.Monitors calibration, maintenance, and equipment/utilities operations ... related to plant maintenance and spare parts procurement systems.Working knowledge of regulatory requirements in accordance with GMPsAbility to work in a highly… more
- Merck & Co. (Rahway, NJ)
- …corrective action/preventive action, procedural controls, auditing and Quality Risk Management .As required, participate in Regulatory Agency inspection ... modules of SAP.Expertise with end-to-end data governance.Expertise with configuration management .Knowledge of published regulatory agency data integrity,… more
- Merck & Co. (Rahway, NJ)
- …of carefully designed clinical trials is critical to drug development.The Specialist , Clinical Trials Communications role within our Research & Development ... key stakeholders and setting agendas for each meetingSupport on legal/compliance/ regulatory reviews on external facing materialsSupport with community engagement and… more
- Merck & Co. (South San Francisco, CA)
- …Responsibilities:Primary responsibility is writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to support ... reports. Interact with colleagues from multiple areas, including discovery, regulatory affairs, project teams, and development functions.Partner with scientists and… more
- Eisai, Inc (Nutley, NJ)
- …mild cognitive impairment due to Alzheimer's disease (AD) or mild AD. TheNeurology Account Specialist (NAS) will be part of a diverse team of sales professionals who ... of their assigned IDNsAccount / market dynamics, stakeholder mapping / management , the HCP referral process, access, account department drivers, patient pathway,… more
- Merck & Co. (Rahway, NJ)
- …produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist , Associate Director, is a subject matter expert in CDISC ... with Health Authority regulations and guidance and company best practices.The Vocabulary Specialist is able to:Work independently, collaboratively as a member of a… more
- Aequor (San Diego, CA)
- …safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing ... commitments and ensuring compliance with global regulatory requirements.Position Summary / ObjectiveAppropriately perform core signal detection activities and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …III as part of the Quality team based in Raritan, NJ. Role Overview The QC Specialist , Lab Services, is responsible for sample management . The QC Specialist ... to resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively. Key Responsibilities… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... applicable environmental, health and safety regulations. Relationships Reports to Senior Specialist EHS at US headquarters in MA. Internal relationships include… more
- Catalent (Manassas, VA)
- …to help create engaging new products consumers will love.The Document Control Specialist - 2nd Shift is responsible for creating and maintaining the Quality ... System documentation. Communicate any deviations to management . Assist the Quality Assurance team with special projects...data; Report any deviations to the Quality Systems and Regulatory Manager in complete, appropriate detail; Review and verify… more
- Merck & Co. (North Wales, PA)
- …DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of our ... full potential. The Associate Director is expected to provide project management leadership and drive cross-functional teams with sufficient influence and mastery… more
