Quality Assurance Associate II

hace 3 semanas

Ciudad de México, Ciudad de México Marken A tiempo completo

Job Title: Quality Assurance Associate II

Job Purpose:

The Quality Assurance Associate II is responsible for overseeing and implementing the Marken Quality Management System (QMS), Standard Operating Procedures (SOPs), processes, and policies required to manage and control Marken's Storage, Distribution, and Transportation, Kit Production Facility. The QAA II must ensure compliance with applicable regional and local regulations and requirements, as well as customer requirements, including current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485, and ISO 9001.

Main Duties and Responsibilities:

  • Implement, communicate, and maintain company quality systems at the facility, in 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 appropriately supported by QA.
  • Oversee an internal audit schedule and perform internal audits, including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA).
  • Perform audits of external service providers as part of the vendor selection process, tracking, and overseeing all commitments for actions or changes made by Marken from previous audits.
  • Host client audits and regulatory inspections, manage audit report responses, and act as Marken's main representative, including preparing appropriate materials required within those audits when applicable.
  • Manage issues and CAPA plans, collate CAPA metrics, and identify and implement quality improvement initiatives. Oversee activities that conclude on the appropriate close-out of all CAPA entries.
  • Identify relevant GxP/Quality-related training needs and deliver or make them available where required.
  • Manage the change control.
  • Ensure the Marken Quality System and GxP Program are implemented and maintained.
  • Assist in the evaluation of Marken-designated vendors and/or outsourced activities.
  • Ensure the accuracy and quality of records and documents.
  • Monitor that training for all personnel is conducted and documented.
  • Coordinate and promptly perform any recall activity.
  • Participate actively in all internal Quality and/or designated meetings.
  • Keep informed of regulatory changes in the country/region and promptly update SOPs as needed.

Additional Responsibilities:

  • Perform QA visual/physical inspection of pharmaceutical products in accordance with internal procedure and client-specific requirements.
  • Perform a review and release of incoming material receipts in accordance with relevant SOPs.
  • Perform verification and approval of label printing process and additional labeling/repackaging activities.
  • Perform QA activities required solo (warehouse movement, inventory status control) for the facility.

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.

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