Quality Assurance Analyst II

hace 2 meses

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 of storage, distribution, and transportation, as well as kit production operations. The QAA II is tasked with ensuring compliance with relevant local and regional regulations, as well as customer specifications, including but not limited to: Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485, and ISO 9001.

Key Responsibilities:

  • Implement and uphold the company's quality systems at the facility, ensuring alignment with Marken's Global Quality Management System (QMS) standards.
  • Engage with clients regarding Quality Assurance (QA) and GxP-related issues.
  • Collaborate effectively with various Marken departments and stakeholders to ensure comprehensive support for all QA activities.
  • Oversee the internal audit schedule, conduct internal audits, and prepare reports while tracking corrective and preventive actions (CAPA).
  • Audit external service providers during the vendor selection process and monitor commitments from previous audits.
  • Facilitate client audits and regulatory inspections, manage audit report responses, and serve as Marken's primary representative during these processes.
  • Address issues and CAPA plans, compile CAPA metrics, and spearhead quality improvement initiatives, ensuring timely closure of all CAPA entries.
  • Identify training needs related to GxP/Quality and ensure training is delivered as necessary.
  • Manage change control processes effectively.
  • Ensure the implementation and maintenance of the Marken Quality System and GxP Program.
  • Assist in evaluating vendors and outsourced activities designated by Marken.
  • Guarantee the accuracy and quality of records and documentation.
  • Monitor and document training for all personnel.
  • Coordinate and execute any necessary recall activities promptly.
  • Actively participate in internal Quality and designated meetings.
  • Stay updated on regulatory changes within the region and promptly revise SOPs as required.

Additional Duties:

  • Conduct visual and physical inspections of pharmaceutical products in accordance with internal procedures and client-specific requirements.
  • Review and authorize incoming material receipts following relevant SOPs.
  • Verify and approve label printing processes and oversee additional labeling and repackaging activities.
  • Execute QA activities related to warehouse movements and inventory status control.

General Expectations:

  • Carry out tasks assigned by QA Management.
  • Travel as needed to fulfill job responsibilities.
  • Support the line manager in establishing effective communication and escalation processes for quality issues.

Qualifications:

  • Minimum of 2 years of relevant experience in a Quality Assurance role within a regulated GSP/GMP/GDP environment.
  • Associate degree or equivalent University Degree/Certification.
  • Knowledge of Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice, and Good Storage Practice guidelines.
  • Familiarity with local regulations.
  • Detail-oriented, organized, and methodical approach to work.
  • Strong interpersonal, oral, and written communication skills.
  • Proficient in Microsoft Office applications.
  • Fluent in English; proficiency in Spanish is preferred.
  • Previous experience with Quality Management Systems is advantageous.

Marken is a subsidiary of UPS, integral to UPS Healthcare, providing a state-of-the-art GMP-compliant depot network and logistics hubs for clinical drug product storage and distribution globally. Marken also supports cell and gene therapy logistics services from clinical to commercial stages, maintaining a leading position in Direct-to-Patient and Home Healthcare services, biological sample shipments, and biological kit production.

Moving Our World Forward by Delivering What Matters.

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