- Eisai, Inc (Nutley, NJ)
- …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 Quality… more
- Aequor (Thousand Oaks, CA)
- …into support of a product distribution function. Skills: ; quality assurance or manufacturing experience in the pharmaceutical industry Must have experience ... with GMP processes and documentation. Without that fundamental skillset the training for document review tasks, label approval and packaging inspection will have no foundation. Must be able to methodically and meticulously inspect printed materials for print… more
- Aequor (Aliquippa, PA)
- …Ensure operations align with applicable regulations and requirements relating to Good Manufacturing Practices, Good Distribution Practices, Good Documentation ... ONSITE AT: Easton, Pennsylvania reporting daily. The candidate will physically work on-site at Langham Logistics, a third-party GMP-compliant warehouse in Pennsylvania. Expected hours: 8:00 AM to 5:00 PM, Monday-Friday.The ideal candidate will have 5&plus… more
- Merck & Co. (Rahway, NJ)
- …Additionally, there are important interactions with, inter alia , Quality Assurance , Finance, Regulatory, Clinical Supplies and legal in a highly matrix-based ... allocation Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) - group and the Good Clinical Practice Quality and Compliance… more
- Twist BioScience (South San Francisco, CA)
- …primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the primary technical and ... with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams to define MES… more
- Aequor (Tampa, FL)
- …List:Bachelor's Degree4&plus years of Audit ExperienceHighly Preferred:Biopharma experienceQuality Assurance experience Purpose and Scope of Position:This role ... with pharmaceutical industry preferredStrong background in Quality Management Systems, Compliance or Quality Assurance preferredExperience in working across cultures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role is key leadership position within Global QMS and Global Quality Assurance . Overall accountability is develop strategic framework work for GxP document ... functions including at least 5 plus years of experience within progressive GxP-Quality Assurance or equivalentMust have a minimum of 5 years of expertise within… more
- Merck & Co. (Rahway, NJ)
- …providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. The position is a key collaborator ... SAS and Python Programming for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance.Excels in technical writing, able… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and that technology-related audits are conducted.Oversee and guide quality assurance processes related to project specifications, ensuring standard procedures are ... programs.Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance.Keep abreast of evolving regulations and industry… more
- Eisai, Inc (Exton, PA)
- …with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program Management departments.The Associate ... cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and other internal (PST) and… more
- AUROBINDO (Durham, NC)
- …an experienced management team with expertise in manufacturing, R&D, Quality Assurance , Quality control, and regulatory affairs. In addition to several formulations ... deliverables associated with various Aurolifesystems such as LIMS, Quality Assurance Management System (QAMS),Waters Empower, Document Management System, Training… more
- BioAgilytix (Durham, NC)
- …quality, access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory requirements, ... systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with regulatory frameworks… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …profile and submit in Zycus for SAP creation.As relevant, liaise with the Quality Assurance group to obtain QA risk rating and audit status for RDP vendors. Maintain ... evaluations. Review and update questions and pending statuses with the Quality Assurance group on a regular basis.Qualifications Successful candidates will be able… more
- Merck & Co. (Rahway, NJ)
- …Control, Mitigation, Organizational Performance Management, Pharmaceutical Quality Assurance , Process Improvement Projects, Process Improvements, Procurement, ... Production Scheduling, Risk Management {+ 5 more}-Preferred Skills:Job Posting End Date:06/14/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed ... aligned with our high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to… more
- Merck & Co. (Rahway, NJ)
- …partnerships with manufacturing sites and partner groupsRegulatory Compliance and Quality Assurance :Ensure that all activities are conducted with the highest regard ... for safety, quality, and regulatory compliance, aligning with the company's divisional and local site procedures.Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971, and other relevant quality management systems. Qualifications:… more
- Merck & Co. (Rahway, NJ)
- …devices or medical device combination products with experience in quality assurance or regulatory oversight of these products.Experience authoring, reviewing and ... approving Quality Management System documents.Solid organizational skills including attention to detail and multi-tasking skills.Effective people skills and ability to work collaboratively across diverse teams and networks, able to foster cooperation in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering NNI Provides ... SME support to employees working within the Deviation process, including consultation on in-process change requests within the scope of the COE Develop and leverages relationships with HQ SMEs, process management, and system management to influence process and… more
- Aequor (Aliquippa, PA)
- …align internal stakeholders toward common goals to ensure consistent supply assurance . Lead demand planning, forecasting, and inventory movement analysis. Maintain ... accurate and timely supply chain metrics. Maintain excellent communication lines across demand and supply sources. Collaborate with quality, finance, process development, and other internal functions. Provide ad hoc reporting and KPI dashboards to support… more
- AUROBINDO (Dayton, OH)
- …of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several ... formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewChemist will perform a variety of QC testing to assess the strength,… more
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