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**Title**: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.- Coordinate and complete Client Quality Questionnaires including supporting documentation as applicable, in accordance with the SOP.- 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