Quality Assurance Specialist

hace 2 semanas

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

Description

Job 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, as well as customer requirements.

Main Duties and Responsibilities:

  • Implement and maintain company quality systems in compliance with Marken's Global QMS requirements.
  • Interact with clients on Quality Assurance (QA)/GxP-related matters under management supervision.
  • Effectively interact with Marken departments and stakeholders to ensure all QA tasks are appropriately supported.
  • Support internal audits and client audits, including preparation of materials required for those audits.
  • Responsible for the QTA process, including ownership of the QTA template from initiation to final signatures and filing.
  • Collate issues, CAPA, Risk Assessment, Change Control, and training metrics, and identify quality improvement initiatives.
  • Ensure the accuracy and quality of records and documents.
  • Participate actively in internal Quality and/or designated meetings.

Requirements:

  • Minimum of 1 year of experience working in a Quality Assurance role within a GSP/GMP/GDP/GCP regulated position.
  • High/Secondary School diploma or equivalent with experience in relevant job-related skills.
  • Related knowledge of Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice, and Good Storage Practice guidelines.
  • Related knowledge of local regulations.
  • Detailed-oriented individual with strong oral and written communication skills.
  • Good interpersonal skills, organized, methodical, and efficient approach to work.
  • Proficient use of Microsoft Office.
  • Fluent in English, multilingual in Spanish and English preferred.
  • Knowledge of Cold chain supplies and logistics, Storage, and distribution for pharmaceutical products preferred.
  • Knowledge and understanding of GDP and ISO Compliance desired.
  • 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. We offer a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and support 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: Moving Our World Forward by Delivering What Matters.

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