Aseptic Manufacturing Expert

hace 15 horas


San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

As a Regulatory Consultant at Qrc Group Llc, you will play a crucial role in ensuring the company's compliance with FDA regulations and guidelines. Your expertise in aseptic manufacturing and FDA product submissions will be invaluable to our team.

Your key responsibilities will include providing expert regulatory advice for aseptic manufacturing processes, preparing and reviewing regulatory submissions to the FDA, and assessing and advising on the regulatory aspects of facility design.

  • Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master's preferred).
  • 5+ years of regulatory experience within the pharmaceutical or biotechnology industry, with a focus on aseptic manufacturing and FDA product submissions.

In this role, you will have the opportunity to work with a talented team of professionals who share your passion for regulatory compliance. You will also have access to ongoing training and professional development opportunities to stay up-to-date with the latest FDA regulations and industry standards.



  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    **Job Description**We are seeking an experienced Aseptic Process Engineer/Lead to support the planning, execution, and completion of key aseptic related projects at Qrc Group, LLC.**Key Responsibilities**Support the development and implementation of aseptic manufacturing processes.Work collaboratively with cross-functional teams to achieve project...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    Job OverviewThe Qrc Group, Llc is seeking a highly skilled Regulatory Consultant to join our team. As a key member of our regulatory affairs department, you will provide expert guidance and support in navigating the complex regulatory landscape.About the RoleIn this critical role, you will be responsible for providing expert regulatory advice for aseptic...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    **Job Overview**The Qrc Group, LLC is seeking an Aseptic Process Engineer/Lead to join our team. This role will be responsible for supporting the planning, execution, and completion of key aseptic related projects.**Responsibilities**Support the design and implementation of aseptic manufacturing processes.Collaborate with cross-functional teams to deliver...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    At Qrc Group Llc, we are seeking a highly experienced Pharmaceutical Engineering Expert to lead our efforts in aseptic processing and system development. The successful candidate will have a strong background in aseptic processing, FDA product submissions, and validation activities.Key responsibilities include:Developing, implementing, and improving aseptic...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    **About the Role**Qrc Group, LLC is seeking an Aseptic Process Engineer/Lead to join our team. This role will be responsible for supporting the planning, execution, and completion of key aseptic related projects.**Responsibilities and Requirements**Support the design and implementation of aseptic manufacturing processes.Collaborate with cross-functional...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    We are seeking a highly skilled Regulatory Consultant to provide expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.The ideal candidate will have strong understanding of FDA regulations and aseptic processing guidelines.Provide expert regulatory advice for aseptic manufacturing processes,...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    About Our TeamWe are a dynamic and innovative organization dedicated to delivering high-quality solutions to our clients. Our team of experts works collaboratively to provide comprehensive support and guidance to our clients.What We OfferWe offer a competitive compensation package, including salary, benefits, and opportunities for professional growth and...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    We are looking for a highly motivated and experienced Regulatory Consultant to join our team at Qrc Group Llc. As a Regulatory Consultant, you will be responsible for providing expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.Your expertise in FDA regulations and aseptic processing guidelines...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    Join Our TeamWe are a collaborative and innovative organization dedicated to delivering high-quality solutions to our clients. As a Regulatory Consultant with Qrc Group, Llc, you will have the opportunity to work with a talented team of experts who are passionate about regulatory affairs.Your Key ResponsibilitiesProvide expert regulatory advice for aseptic...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    Key ResponsibilitiesLead and manage complex projects related to the development, validation, and commercialization of aseptic pharmaceutical or medical device products.Coordinate and oversee all stages of project execution from design, development, and validation through to FDA submission.Develop project timelines, resource allocation plans, and budgets,...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    We are looking for a Regulated Pharmaceutical Process Lead to join our team at Qrc Group Llc. As a key member of our organization, you will be responsible for leading efforts in designing, implementing, and improving aseptic processes and systems within a regulated pharmaceutical environment.The successful candidate will have a strong background in aseptic...


  • San Juan, San Juan, Puerto Rico Esw Manufacturing, Inc. A tiempo completo

    Cualificaciones y habilidades requeridasConocimiento en Microsoft Word y ExcelExperiencia previa en atención al clienteDinámica y buenas relaciones interpersonalesSe requiere experiencia en cuadro telefónico y conocimiento en dinámica para el manejo de múltiples tareas simultáneamente. La selección del candidato dependerá de su capacidad para brindar...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    About the Role">We are seeking an experienced CSV specialist to join our team as a software compliance expert. In this role, you will be responsible for ensuring that our software products meet the highest standards of quality and compliance.">Key Responsibilities">You will be responsible for performing validation activities on software and manufacturing...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    We are seeking an experienced Csv Specialist to join our team at Qrc Group, Llc. In this role, you will be responsible for performing validation activities on software and manufacturing equipment in the medical device industry.Responsibilities:Validating software and medical devices equipmentDeveloping and implementing validation protocolsEnsuring compliance...