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Quality Assurance Associate II

hace 2 meses


Xico, México Marken A tiempo completo

Job Summary

The Quality Assurance Associate II is responsible for overseeing and implementing the Marken Quality Management System (QMS), ensuring compliance with regulatory requirements and customer expectations. This role involves interacting with clients, internal stakeholders, and external service providers to maintain quality standards.

Main Responsibilities

  • Implement and maintain the QMS, ensuring compliance with Marken's Global Quality Management System (QMS) requirements.
  • Interact with clients on Quality Assurance (QA)/GxP-related matters.
  • Effectively interact with Marken departments and stakeholders to ensure all QA tasks are supported.
  • Oversee internal audit schedules, perform internal audits, and track 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.
  • Ensure the accuracy and quality of records and documents.
  • Monitor training for all personnel and document it.
  • Coordinate and perform recall activities.
  • Participate in internal Quality and designated meetings.

Additional Responsibilities

  • Perform QA visual/physical inspections of pharmaceutical products in accordance with internal procedures and client-specific requirements.
  • Review and release incoming material receipts in accordance with relevant SOPs.
  • Verify and approve label printing processes and additional labeling/repackaging activities.
  • Perform QA activities required for the facility, including warehouse movement and inventory status control.

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.