Quality Assurance Associate

Job Purpose: 

The purpose of the QA Associate role is to facilitate, manage, and oversee the implementation of the Marken Quality Management System (QMS) at the Local Branch. The Quality Management System is a collective, interrelated and interactive group of defined processes and procedures that must be implemented and adhered to in order to achieve and maintain a high- quality standard. These processes and procedures incorporate the requirements of ISO 9001:2015 accredited program and adherence to the principles of Good Distribution Practices, Marken Quality Standards (SOPs), local laws and authority regulations, and customer requirements. 

Main Duties and Responsibilities: 

• Implement, communicate and maintain company’s quality systems, in compliance with Marken’s Global quality management system requirements. 

• Agree standards and define quality processes and procedures through effective controlled document issue and management. 

• Liaise with clients on QA and GDP related matters. 

• Prepare an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA). 

• Prepare an external audit program and 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 customer audits. 

• Host client audits and regulatory inspections and manage the audit report responses. Acting as Marken’s main representative for customer audits, including the preparing of appropriate materials required within those audits. 

• Manage CAPA plans, collate CAPA data, and identify and implement quality improvement initiatives. Preparing the CAPA log for the site and overseeing activities that conclude on the appropriate close-out of all CAPA entries. 

• Ensuring that relevant customer complaints are dealt with effectively and completely. 

• Ensure the local implementation of Client Technical (Quality) and Service Level Agreements. 

• Identify relevant GDP/ quality related training needs and deliver training where required. 

• Manage the change control system for Marken Miami. 

• Ensuring that the Marken Quality System and GDP Program are implemented and maintained. 

• Assisting in the evaluation of Marken-designated vendors and/or out-sourced activities. 

• Ensuring the accuracy and quality of records and documents. 

• Ensuring that training for all personnel involved in the processes of transportation of medicinal products is conducted and documented. 

• Coordinating and promptly performing any recall activity declared by Marken senior quality management. 

• Keeping records of all qualification and validation activities performed for critical equipment. 

Requirements: 

• Previous experience in Quality Management Systems with an eye for details 

• Knowledge of GxP 

• Good interpersonal skills, conflict mediation, sense of urgency to complete assignments on time 

• Ability to analyze and work in detail 

• 2+ years of relevant experience, including Quality and Logistics experience in Pharmaceutical/ biotechnology industry experience a plus 

• Finishing or recently graduated of a bachelor related to Pharmacy or similar 

• Bi-lingual in Spanish