Quality Assurance Associate II

hace 3 días

Ciudad de México, Ciudad de México Marken A tiempo completo
Job Title: Quality Assurance Associate II

Job Summary:

The Quality Assurance Associate II is responsible for ensuring the implementation and maintenance of Marken's Quality Management System (QMS) and Good Manufacturing Practice (GMP) guidelines. This role involves interacting with clients, internal departments, and stakeholders to maintain quality standards and ensure compliance with regulatory requirements.

Main Responsibilities:
  • Implement and maintain company quality systems in compliance with Marken's QMS requirements.
  • Interact with clients on Quality Assurance (QA)/GxP-related matters.
  • Effectively interact with Marken departments and stakeholders to maintain that all QA tasks are appropriately supported by QA.
  • Oversee internal audit schedules and perform internal audits, including report preparation and assessment of corrective and preventive actions (CAPA).
  • Perform audits of external service providers as part of the vendor selection process.
  • Host client audits and regulatory inspections, manage audit report responses, and act as Marken's main representative.
  • Manage issues and CAPA plans, collate CAPA metrics, and identify quality improvement initiatives.
  • Identify relevant GxP/quality-related training needs and deliver or arrange for delivery where required.
  • Manage change control and ensure the accuracy and quality of records and documents.
  • Monitor training for all personnel and coordinate recall activities.
  • Participate in internal Quality and/or designated meetings and stay informed of regulatory changes in the country/region.
Requirements:
  • 2+ years of relevant experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position.
  • Associate degree and/or equivalent University Degree/Certification.
  • Related knowledge of Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice, and Good Storage Practice guidelines.
  • Related knowledge of local regulations.
  • Detailed-oriented, organized, methodical, and efficient approach to work.
  • Good interpersonal, oral, and written communication skills.
  • Proficient use of Microsoft Office.
  • Fluent in English, multilingual in Spanish and English preferred.
  • Previous experience in Quality Management Systems preferred.

About Marken:

Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments, and biological kit production.

Mission Statement:

Moving Our World Forward by Delivering What Matters.

  • Quality Assurance Associate II

    hace 4 semanas

    Ciudad de México, Ciudad de México Marken A tiempo completo

    Job Title: Quality Assurance Associate IIMarken, a leading provider of clinical drug product storage and distribution services, is seeking a highly skilled Quality Assurance Associate II to join our team.Job Purpose:The Quality Assurance Associate II will be responsible for ensuring the implementation and maintenance of Marken's Quality Management System...

  • Quality Assurance Associate II

    hace 4 semanas

    Ciudad de México, Ciudad de México Marken A tiempo completo

    Job Title: Quality Assurance Associate IIMarken, a leading provider of clinical drug product storage and distribution services, is seeking a Quality Assurance Associate II to join our team.Job Purpose:The Quality Assurance Associate II will be responsible for ensuring the quality and compliance of our services, including the oversight and implementation of...

  • Quality Assurance Associate II

    hace 3 semanas

    Ciudad de México, Ciudad de México Marken A tiempo completo

    Job Title: Quality Assurance Associate IIDescriptionTitle: Quality Assurance Associate II Job Purpose:The Quality Assurance Associate II (QAA II) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken's...

  • Quality Assurance Associate

    hace 2 semanas

    Ciudad de México, Ciudad de México Marken A tiempo completo

    Job Title: Quality Assurance AssociateMarken, a leading provider of temperature-controlled logistics and distribution services, is seeking a Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and integrity of our temperature-controlled logistics and distribution services.Key...

  • Quality Assurance Associate

    hace 2 semanas

    Ciudad de México, Ciudad de México Marken A tiempo completo

    Job SummaryWe are seeking a highly skilled Quality Assurance Associate to join our team at Marken. As a Quality Assurance Associate, you will be responsible for ensuring the quality and compliance of our products and services.Key ResponsibilitiesImplement and maintain our quality management system, ensuring compliance with regulatory requirements and company...

  • Quality Assurance Analyst II

    hace 1 mes

    Ciudad de México, Ciudad de México Marken A tiempo completo

    Job Overview Position: Quality Assurance Associate II The Quality Assurance Associate II (QAA II) plays a crucial role in overseeing and executing the Quality Management System (QMS) at Marken. This position is essential for ensuring adherence to the established Standard Operating Procedures (SOPs), processes, and policies that govern the management...

  • Quality Assurance Associate II

    hace 1 mes

    Ciudad de México, Ciudad de México Marken A tiempo completo

    Job SummaryWe are seeking a highly skilled Quality Assurance Associate II to join our team at Marken, a leading provider of clinical drug product storage and distribution services. The successful candidate will be responsible for ensuring the quality and compliance of our operations, including the oversight and implementation of our Quality Management System...

  • Quality Control Associate II

    hace 1 mes

    Ciudad de México, Ciudad de México Marken A tiempo completo

    Job Overview Position: Quality Assurance Associate II The Quality Assurance Associate II (QAA II) plays a pivotal role in the management and execution of the Marken Quality Management System (QMS). This position ensures adherence to established Standard Operating Procedures (SOPs), processes, and policies necessary for the effective management of...

  • Quality Assurance Associate

    hace 4 semanas

    Ciudad de México, Ciudad de México Marken A tiempo completo

    Job Title: Quality Assurance AssociateDescriptionTitle: Quality Assurance AssociateJob Purpose: As a Quality Assurance Associate at Marken, you will play a critical role in ensuring the implementation and maintenance of our Quality Management System (QMS) and Standard Operating Procedures (SOPs). You will be responsible for ensuring compliance with...

  • Quality Assurance Specialist II

    hace 1 mes

    Ciudad de México, Ciudad de México Marken A tiempo completo

    Job Overview The Quality Assurance Associate II plays a pivotal role in ensuring the integrity and compliance of the Marken Quality Management System (QMS). This position is crucial for the management and execution of the Standard Operating Procedures (SOPs), processes, and policies that govern Marken's Storage, Distribution, and Transportation, as...

  • Quality Assurance Engineer II

    hace 3 semanas

    Ciudad de México, Ciudad de México Servicios Comerciales Amazon Mexico S. de R.L. de C.V. - D44 A tiempo completo

    About the RoleWe are seeking a highly skilled Quality Assurance Engineer II to join our Amazon Photos team. As a QAE, you will collaborate with cross-functional teams to design, develop, and execute comprehensive test strategies, test plans, and manual test cases to validate new features.Key ResponsibilitiesBuild and maintain test infrastructure for a...

  • Quality Assurance Specialist II, Amazon Photos

    hace 1 mes

    Ciudad de México, Ciudad de México Servicios Comerciales Amazon Mexico S. de R.L. de C.V. - D44 A tiempo completo

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist II to join our Amazon Photos team in Mexico. As a Quality Assurance Specialist II, you will play a critical role in ensuring the quality of our product by designing, developing, and executing comprehensive test strategies, test plans, and manual test cases.Key ResponsibilitiesDesign...

  • Quality Assurance Engineer II

    hace 2 días

    Ciudad de México, Ciudad de México Servicios Comerciales Amazon Mexico S. de R.L. de C.V. - D44 A tiempo completo

    About the RoleWe are seeking a highly skilled Quality Assurance Engineer II to join our team at Amazon Photos. As a QAE, you will collaborate with Developers, Software Developers in Test, QAEs, QA managers, Software Development Engineers, Product managers, and Technical program managers to deliver high-quality software products.Key ResponsibilitiesDesign,...

  • Quality Assurance Specialist

    hace 2 semanas

    Ciudad de México, Ciudad de México Marken A tiempo completo

    Job Title: Quality Assurance AssociateDescriptionJob Purpose: As a Quality Assurance Associate at Marken, you will play a critical role in ensuring the implementation and maintenance of our Quality Management System (QMS) and Standard Operating Procedures (SOPs). You will be responsible for ensuring compliance with applicable regional and local regulations,...

  • Quality Assurance Expert

    hace 10 horas

    Ciudad de México, Ciudad de México Work Visa USA Jobs (move2usajobs LLC) A tiempo completo

    Quality Assurance Specialist OpportunityAn exciting chance to bring your expertise and precision to the United States is available for Quality Assurance Specialists. This role is designed for professionals dedicated to ensuring product and service excellence, enhancing customer satisfaction, and contributing to the continuous improvement of processes within...

  • Quality Assurance Manager

    hace 4 días

    Ciudad de México, Ciudad de México Lear Corporation A tiempo completo

    {"title": "Quality Assurance Manager", "content": "Join Lear CorporationWe are a global leader in the automotive industry, and we are seeking a Quality Assurance Manager to join our team.As a Quality Assurance Manager, you will be responsible for ensuring that our products meet the highest standards of quality and safety.Key Responsibilities:Lead the...

  • Quality Assurance Specialist

    hace 4 semanas

    Ciudad de México, Ciudad de México Reser's Fine Foods, Inc. A tiempo completo

    Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Food Technician to join our team at Reser's Fine Foods, Inc.Key ResponsibilitiesMonitor and document key process control points during production operations to ensure food safety and quality.Participate in the determination of corrective actions to address any food safety or...

  • Quality Assurance Expert

    hace 11 horas

    Ciudad de México, Ciudad de México Work Visa USA Jobs (move2usajobs LLC) A tiempo completo

    Job Opportunity:An exceptional chance to excel in the field of Quality Assurance has emerged in the United States. This role is designed for dedicated professionals who can bring their expertise and precision to ensure product and service excellence, enhance customer satisfaction, and contribute to the continuous improvement of processes within a dynamic...

  • Associate Quality Assurance Specialist

    hace 1 día

    Ciudad de México, Ciudad de México Global Payments A tiempo completo

    Quality Assurance AnalystAt Global Payments, we're committed to delivering best-in-class payment technology and software solutions. As a Quality Assurance Analyst, you'll play a critical role in ensuring the quality and reliability of our products and services.Key Responsibilities:Assist in conducting online, batch, and data verification testing to ensure...

  • Clinical Research Associate II

    hace 2 semanas

    Ciudad de México, Ciudad de México PSI CRO A tiempo completo

    Job Title: Clinical Research Associate IIAt PSI CRO, we are seeking a highly skilled Clinical Research Associate II to join our team. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials.Key Responsibilities:Conduct and report onsite monitoring visits to ensure the highest quality standards in the industry.Be...