- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control/QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am EST - ... 4:30 pm EST.The Document Control/QA Associate I will report directly to the...Management System. This role is responsible for assisting the document control department in processing documentation requests. They will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/ Document Audits supports end-to-end audit activities per audit program of GxP ... as appropriate for the area of GxP audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and Common Technical Document … more
- Aequor (Athens, GA)
- …/ activities. Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy systems. Electronic ... Document Management (controlled documents, regulatory submission documents): Create and...Management (controlled documents, regulatory submission documents): Create and configure document templates and support site users in workflow configuration.… more
- Merck & Co. (Rahway, NJ)
- …independent auditing, review, and approval of diverse and complex document types, as required, including deviations, investigations, change records, analytical ... practices are accurately reflected. Assist in SOP and quality-related system document approval. Support metrics by summarizing findings during documentation reviews.… more
- Merck & Co. (North Wales, PA)
- …care systems that can enhance value and use of products.Implements programs to document the burden and cost of diseases, unmet medical need, patient reported ... and reimbursement dossier, which includes the development of the worldwide template document including global value dossier and input forms, design of data… more
- Repligen (Waltham, MA)
- …supplier changes. Nonconforming Material Request (NCMR) Process and AnalysisInitiate and Document NCMRs: Identify and document nonconforming material detected ... during incoming inspection, production, or customer complaints. Ensure accurate logging of issue details, affected part numbers, quantities, and supplier information.Data Analysis and Trend Reporting: Analyze NCMR data to identify recurring issues, high-risk… more
- Merck & Co. (Rahway, NJ)
- …responsible for preparing responses to Internal Revenue Service Information Document Requests ("IDRs"), gathering information, preparing analyses to support ... gather necessary information.Key ResponsibilitiesPrepare detailed responses to IRS Information Document Requests (IDRs), ensuring all information is comprehensive and… more
- Merck & Co. (South San Francisco, CA)
- …development. PDMB aims to leverage Generative AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory ... review process. -Implement strategies to leverage GenAI for improving document quality and consistency.Education Minimum Requirements: -Ph.D. in Computer Science,… more
- Merck & Co. (Upper Gwynedd, PA)
- …communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory leadership as needed in product ... Biological Sciences, Biologics License Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance, Microbiology, Molecular Microbiology,… more
- Aequor (Pearl River, LA)
- …from raw data acquisition to data visualization and data analysis. Develop, document , and maintain reproducible computational pipelines and scripts using R and ... to detail in managing multiple projects and deadlines. Ability to document code thoroughly to ensure reproducibility and clarity for collaborative projects.Hard… more
- Formation Bio (New York, NY)
- …within transformation layers-using LLMs for named entity recognition, document summarization, classification, and schema alignment. Write robust, testable, ... frameworks to ensure quality, trust, and reproducibility of datasets. Document transformation logic, assumptions, and data lineage in collaboration with… more
- Twist BioScience (South San Francisco, CA)
- …and in alignment with business needs and strategic objectives.Gather and document detailed business requirements for projects, ensuring clarity and alignment across ... experience.Excellent communication, collaboration, and relationship-building skills.Ability to gather and document detailed business requirements and work with users to… more
- Twist BioScience (South San Francisco, CA)
- …and collaborate with the Business Process Owner and EQMS users to develop and document configuration changes to meet business need Perform other duties & projects as ... SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems (eQMS) Experience with Google Suite and/or MS Office… more
- Merck & Co. (Rahway, NJ)
- …Business, Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document Control Systems, Electronic Common Technical Document ... (eCTD), Ethical Compliance, Global Health, Global Program Development, High Performance Team Building, Human Resource Management, Immunoassays, Immunology, Immunotherapy, Management Process, Medical Devices, Mentoring Staff, Ophthalmology, Pathophysiology,… more
- Merck & Co. (Rahway, NJ)
- …outcomes across large organizations.Strong communicator who can clearly document workflows, governance decisions, and integration logic.Current Employees apply ... HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation… more
- Merck & Co. (Rahway, NJ)
- …insights.Ensure data accuracy, consistency, and security across all BI solutions. Document processes, data models, and solutions; provide training to end-users ... during tool transitions. Required Skills and Qualifications Experience: 3+ years in BI development, data analysis, or a related role.Proficiency with BI Tools (Qlik Sense, Power BI, ThoughtSpot is a plus).Strong expertise in writing and optimizing SQL queries… more
- Merck & Co. (Austin, TX)
- …test planning, safety validation, change control, and rollback design. Document technical implementations, integration patterns, and decision logic.Collaborate with ... engineers and domain owners to identify automation opportunities.Apply cybersecurity understanding to ensure automation is relevant, secure, and impactful.Required Qualifications:1-2 years of hands-on experience in security engineering, IT automation, or… more
- Aequor (Pearl River, LA)
- …various assays to monitor immune responses elicited by vaccine candidates and document laboratory work in electronic notebooks thoroughly. - Maintain cell lines, ... process tissues such as spleens, lymph nodes and PBMCs, and prepare samples for testing, assisting with molecular and virology work. - Ensure compliance with SOP guidelines, cGLP, and/or cGMP guidelines, and execute qualifications and validations of new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …evidence generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with ... GMA Clinical Operations and other cross-functional and regional stakeholders.- Provides support in review of investigator-initiated studies (IIS) and may serve as deputy compound lead in Global IIS Review Committee meetings.- Leads selecting medical education… more
- Aequor (East Syracuse, NY)
- …downstream manufacturing process development, characterization, and process improvements. Document and evaluate experimental results and perform data verification ... and trending. Provide technical expertise and guidance to support investigations and help troubleshoot analytical operational issues. Identify new analytical technologies and opportunities for technical advancements. Support the preparation and review of… more
