- Merck & Co. (Rahway, NJ)
- …procedures.Prepare the Final Study Report Maintain contact with all stakeholders (project leader, regulatory affairs , quality assurance etc.) and keeps ... and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires… more
- Merck & Co. (Rahway, NJ)
- …Demonstrated sound understanding of related fields (eg, manufacturing, process development, analytical, quality assurance ) and the ability to be creative and ... Capability, People Leadership, Policy Implementation, Project Management, Project Tasks, Regulatory Affairs Compliance {+ 4 more}-Preferred Skills:Job Posting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... SM) and relevant external stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC and EU):in an efficient… more
- Merck & Co. (Rahway, NJ)
- …to deliver objectives.Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice ... ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory , Pharmacovigilance (PV) and Medical Affairs .Responsible and supports… more
- Twist BioScience (South San Francisco, CA)
- …the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams to ... MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the… more
- Pall (Miami, FL)
- …fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO 9001 and AS9100 / CAA Part ... the Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations… more
- AUROBINDO (Durham, NC)
- …management team with expertise in Manufacturing, R&D, Quality Assurance , Quality Control and Regulatory Affairs . In addition to several formulations ... and investigations under the direction of a supervisor.Comply with all regulatory /in-house requirements (may include but not limited to safety, house keeping,… more
- AUROBINDO (Dayton, OH)
- …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 Overview-1. Cleaning and organizing the Laboratory Glassware 2. Remove of liquid and solid… more
- Integrated DNA Technologies (IDT) (Miami, FL)
- …stakeholders.Work closely with cross-functional teams, including Scientific Application Support (SAS), Quality Assurance , Regulatory Affairs , Product ... that safeguard and improve human health.This position is part of the Quality Assurance Department located in Coralville, IA and will be on-site. At IDT,… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …ideal place to build your career.Job SummaryDirects the activities of the Quality Assurance and Regulatory Affairs department. Ensures the quality ... and regulatory systems are effectively implemented and maintained.Essential Functions + Pre-market approval of new and modified medical devices in domestic and international markets. + Post-market surveillance and medical device reporting in domestic and… more
- Fujifilm (College Station, TX)
- **Position Overview** **Summary:** The Quality Assurance Regulatory Affairs Supervisor is responsible for supporting the electronic publishing of ... competencies, or as part of an individual's development plan. Regulatory Affairs supports all CMC regulatory...of two (2) years of related experience in a regulatory , quality , or similar position. + Prior… more
- Tecomet (Manchester, NH)
- **POSITION SUMMARY:** The Quality Assurance & Regulatory Affairs Manager oversees the quality management system (QMS) and ensures compliance with 21 ... device industry; + 5+ years of experience in quality assurance and regulatory affairs within a regulated industry (medical devices preferred); **WORK… more
- FlexStaff (Melville, NY)
- **Req Number** 162058 FlexStaff is seeking a Quality Assurance Associate for a long term temporary role with our client, a leading distributor of health care ... Rate: $27/hr This position is responsible to support the Quality Assurance and Trade Compliance teams in...803, 806 etc.) Responsibilities: + Data entry in various quality and regulatory management systems + Assist… more
- Bausch + Lomb (Harrisburg, PA)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance , Pharmacovigilance/GPSS ... ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,...timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house… more
- University of Miami (Miami, FL)
- …overseeing the creation and maintenance of policies and procedures as they relate to regulatory affairs , quality assurance , financial affairs , ... and UM policies and procedures. + Work with the Regulatory Manager and Financial Manager in the development and...protocol's development, and its preparation for implementation. Working with Quality Assurance staff, ensure all required systems… more
- ManpowerGroup (Plymouth, MN)
- …+ Experience in the medical **device** industry. + Background in ** regulatory affairs ** , ** quality assurance (QA)** , or **clinical/medical** fields. + ... documentation, coding, and analysis related to medical devices, supporting regulatory and quality assurance processes. This is an excellent opportunity… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance , Medical Affairs ... strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety… more
- Merck (De Soto, KS)
- …+ Prepare the Final Study Report + Maintain contact with all stakeholders (project leader, regulatory affairs , quality assurance etc.) and keeps them ... and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance , Medical Affairs ... strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees, MAAs, NDAs, and BLAs; provide medical… more
- Curia (Albuquerque, NM)
- …CAPA + Demonstrated understanding of laboratory, manufacturing, packaging, regulatory affairs , compliance, and quality assurance requirements for ... as commercial manufacturing operations. The role provides clear guidance on quality requirements consistent with cGMPs, regulatory expectations, and industry… more
