Senior Quality Assurance Specialist

hace 15 horas


Xico, México Marken A tiempo completo

Job Overview

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Marken, a leading provider of clinical drug product storage and distribution services. In this role, you will be responsible for overseeing the implementation and maintenance of our Quality Management System (QMS) and ensuring compliance with regulatory requirements.

About the Role

The Senior Quality Assurance Specialist will play a critical role in maintaining our company's high standards of quality and customer satisfaction. Your primary responsibilities will include:

  • Implementing and communicating QMS policies and procedures to ensure compliance with regulatory requirements.
  • Conducting internal audits and vendor evaluations to identify areas for improvement.
  • Managing CAPA plans and tracking corrective actions to ensure timely resolution.
  • Providing training and guidance to employees on QMS-related topics.
  • Coordinating client audits and regulatory inspections to ensure smooth execution.
  • Ensuring accuracy and quality of records and documents.

Requirements

To succeed in this role, you will need:

  • 2+ years of experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position.
  • An Associate degree and/or equivalent University Degree/Certification.
  • Detailed knowledge of Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice, and Good Storage Practice guidelines.
  • Excellent communication and interpersonal skills.
  • Proficient use of Microsoft Office.
  • Fluent in English, with Multilingual skills preferred.

Salary Range

$80,000 - $110,000 per year, depending on experience.



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