DirecciónTitle:
Quality Assurance Associate
Job Purpose:
The Quality Assurance Associate I (QAA I) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies.
The QAA I also needs to ensure compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Clinical Practices (GCP), Good Storage Practices (GSP), ISO 13485 and ISO 9001.
Main Duties and Responsibilities:
- Implement, communicate and maintain company’s 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 maintain that all QA tasks are appropriately supported by QA.
- Support on internal audits.
- Support client audits and regulatory inspections, including the preparation of appropriate materials required within those audits when applicable.
- Responsible for the QTA process, including ownership of the QTA from initiation of the QTA template through to final signatures and filing; assigning a QTA # and PRA # if applicable, and assuring compliance to the SOP, including ensuring a QTA is updated or retired appropriately.
- Collate issues, CAPA, Risk Assessment, Change Control and training metrics and identify 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 training where required.
- Ensuring that the Marken Quality System and GxP Program are implemented and maintained.
- Ensuring the accuracy and quality of records and documents.
- Participate actively in all the 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 skill
- Related knowledge of Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice and Good Storage Practice guidelines
- Related knowledge of local regulations
- Detailed oriented
- 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
Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports 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.
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