- Merck & Co. (Rahway, NJ)
- …responsibilities include but are not limited to the following: Perform quality assurance activities related to API manufacturing in a complex, clinical supply ... with all stakeholders in all manufacturing operations, analytical testing, quality assurance , regulatory, etc. at all levels. Establish, educate, and enforce… more
- Insmed Incorporated (San Diego, CA)
- …Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance , the Director of Clinical Quality Assurance (CQA) serves ... use and provides direction, guidance and strategy for company Quality Assurance .Full understanding of and practical experience establishing and fostering compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Education Level: Bachelor's degree required (healthcare provider required); relevant experience may substitute for degree, when appropriate; advanced degree preferred ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies… more
- Aequor (Thousand Oaks, CA)
- …Bachelor's Degree in Science OR Associate's Degree in Science and 3 years of experience in biotechnology/Pharma environment. OR 3 years of experience in regulated ... Location: Thousand Oaks, CA - 100% onsite Contract Duration: 3 years Standard business hours The ideal candidate will have a strong attention to detail, effective time management, and clear communication skills. They should have at least a high school diploma… more
- Aequor (Thousand Oaks, CA)
- …industry experience will not be considered. This position supports 's Quality Assurance program under the Plant QA organization providing daily oversight of the ... Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental… more
- 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
- Merck & Co. (Rahway, NJ)
- …medical innovation and help improve lives.Our Company's Corporate Audit and Assurance Services' (MCAAS) primary purpose is to provide value-added independent and ... risk-based audit and assurance services.Position Overview / Function and ResponsibilityThe Associate Director:Leads a small team through financial and compliance… more
- Repligen (Waltham, MA)
- …appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality, or related technical ... of experience in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001 audits and supplier quality… 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
- Eisai, Inc (Raleigh, NC)
- …Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and ... products and/or Biologics is a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record review, SOP writing,… more
- Aequor (Houston, TX)
- …with others across the team o Routine interaction with Quality Assurance (Raw Materials) and other interdepartmental members to communicate investigational current ... able to work well within a team. Routine interaction with Quality Assurance and other Quality departments to communicate investigational current status, alignment… more
- Repligen (Waltham, MA)
- …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 ... with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules; serve as host for… 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
- Merck & Co. (Rahway, NJ)
- …Administrative Policies, Capital Projects, Collective Bargaining, Compliance Assurance , Computerized Maintenance Management Systems (CMMS), Digital Transformation, ... Driving Continuous Improvement, Emerging Technologies, Energy Efficiency, Equipment Maintenance, GMP Compliance, HVAC Systems, Key Performance Indicators (KPI), Maintenance Management, Maintenance Processes, Managing Change Requests, People Leadership, Plant… 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
- 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
- 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
- Tris Pharma (Monmouth Junction, NJ)
- …required documentations, in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of ... Change Control Reports (CCRs), methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management, conducts laboratory investigations and recommends appropriate Corrective Action… more
- Repligen (Hopkinton, IA)
- …adjustments to meet production targets.Inspect products for quality assurance and report defects or inconsistencies.Communicate effectively with supervisors ... and other departments (maintenance, quality, engineering).Assist with scheduling, timekeeping, and attendance tracking.Identify and report equipment issues or process inefficiencies.Maintain production records, logs, and reports.Other Duties:Please note this… more
- Repligen (San Diego, CA)
- …and antibodies in drug discovery and development, manufacturing, and quality assurance . The Laboratory Support Specialist will provide support both at CTI/Repligen ... and on site at customer locations. The type of support will include system qualifications for Installation and Operation (IQOQ), product testing, system maintenance and customer training. Delivering training and support will involve travelling to customer… more
