QA Associate - Marken

Overview

Join or sign in to apply for the QA Associate - Marken role at UPS . Marken, UPS Healthcare Precision Logistics (formerly Marken, MNX & Polar Speed), the clinical and advanced therapy subsidiary of UPS Healthcare, unites expertise across healthcare and complex secure logistics to drive the success of our clients through innovation.

Explore opportunities at a Fortune Global 500 company. We value people with outstanding skill and passion who can lead teams and grow their abilities to take UPS forward.

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 QMS is a group of defined processes and procedures that must be implemented and adhered to to achieve and maintain a high-quality standard. These processes incorporate ISO 9001 : 2015 requirements, Good Distribution Practices, Marken Quality Standards (SOPs), local laws and authority regulations, and customer requirements.

Main Duties And Responsibilities

• Implement, communicate and maintain the 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 corrective and preventive actions (CAPA).
• Prepare an external audit program and perform audits of external service providers as part of vendor selection. Track and oversee commitments for actions or changes from previous customer audits.
• Host client audits and regulatory inspections and manage the audit report responses. Act as Marken’s main representative for customer audits, including preparation of required materials.
• Manage CAPA plans, collate CAPA data, and identify and implement quality improvement initiatives. Prepare the CAPA log for the site and oversee close-out of all CAPA entries.
• Ensure relevant customer complaints are dealt with effectively and completely.
• Ensure local implementation of Client Technical (Quality) and Service Level Agreements.
• Identify relevant GDP / quality training needs and deliver training where required.
• Manage the change control system for Marken Miami.
• Ensure Marken Quality System and GDP 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.
• Ensure training for personnel involved in the transportation of medicinal products is conducted and documented.
• Coordinate and promptly perform any recall activity declared by Marken senior quality management.
• Keep records of all qualification and validation activities for critical equipment.

Requirements

Tipo De Empleado

Permanente

UPS se compromete a proporcionar un lugar de trabajo libre de discriminación, acoso y represalias.

Seniority level

Entry level

Employment type

Full-time

Job function

Quality Assurance

Industries

Truck Transportation

Location and application notes : Santiago, Chile area

#J-18808-Ljbffr