Quality Coordinator

Marken, a UPS Company - Miami, FL3.0

Full-timeEstimated: $49,000 - $67,000 a year
Skills

About Marken

At Marken, we challenge every employee to take the initiative and achieve outstanding results. We recognize that talent is our most important asset and we offer the training, education and growth opportunities to take your career to the next level.

Marken is a wholly owned subsidiary of UPS. Marken is the only patient-centric supply chain organization 100% dedicated to the pharmaceutical and life sciences industries. Marken maintains the leading position for Direct to Patient services and biological sample shipments and offers a state-of-the-art GMP-compliant depot network and logistic hubs in 48 locations worldwide for clinical trial material storage and distribution. Marken’s more than 950 staff members manage 50,000 drug and biological shipments every month at all temperature ranges in more than 150 countries. Additional services such as biological kit production, ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.

Our global presence, combined with a small company culture, provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to contribute to the company’s success.

Job Description:

The purpose of the Quality Coordinator role is to facilitate, manage, and oversee the implementation of the Marken Quality Management System (QMS) at the Local Branch including but not limited to support of Direct to Patient (DTP services). 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, Good Manufacturing Practices, Marken Quality Standards (SOPs), local laws and authority regulations, and customer requirements.

Main Duties and Responsibilities:

  • Identify inconsistencies and/or deficiencies in the QMS and report them to the Branch Management and Quality Assurance Management
  • Initiate issue escalation to circumvent failures within the Logistics Branch
  • Oversee and review quality issue reporting, resolution (CAPA) and follow up, including completion of Client Issue Reports and insure effectiveness checks are performed
  • Assist Line Management and Quality with initial and continuous training
  • Ensure local quality records are maintained in accordance with the QMS (quality reports, complaint information, relevant copies of audit reports, personnel training files)
  • Archive management (procedures and timelines adhered to)
  • Perform internal audits, assist with audit preparations, attend audits and complete audit reports and drive follow up and resolution as needed
  • Support and/or lead customer audits, including preparation, attend audit execution and ensure that all related action items are resolved in a timely and accurate manner
  • Assists in the evaluation and assessment of Marken-designated agents and/or out-sourced activities
  • Assist with the collection of Key Performance Indicator (KPI) data and reporting and the production of KPI metrics to monitor and drive continuous improvement within the Branch
  • Maintain general Quality, Health and Safety standards within the branch
  • Define and execute training to improve understanding of and compliance with procedures and quality requirements
  • Define and support initiatives to improve the performance of the branch
  • Support other QA/QC activities as needed

Requirements:

  • A minimum of 10 years in the transportation/logistics industry
  • Experience working in a compliance role, ideally with exposure to GDP, GMP and QMS environment
  • Experience in driving the daily workload and performance based on data (shipment/milestone reports, KPI matrix etc.)
  • Experience with airfreight operations, import/export operations and related regulatory requirements is an advantage (e.g. TSA, US CBP, FDA)
  • Driving win-win outcomes in situations of conflict, escalations and customer complaints
  • Demonstrated training skills
  • Expertise skills in defining and writing procedures and work instructions
  • Organized, and a mind for paying attention to details
  • Structured and solution driven thinking
  • Excellent communication and writing skills
  • Ability to drive successful outcomes when working in a cross-functional environment
  • Solid experience in working with MS Office (Outlook, Word, Excel)

VETERAN AND EEO Employer

Job Type: Full-time

Experience:

  • Airfreight operations (TSA, US CBP , FDA): 1 year (Preferred)
  • Compliance role in GDP and/or GMP environment: 1 year (Preferred)
  • CAPA oversignt/resolution: 1 year (Preferred)
  • transportation/logistics industry: 1 year (Preferred)
  • Quality Management Systems: 1 year (Preferred)

Work authorization:

  • United States (Required)