Reputable Pharmaceutical Supply Chain organization in Doral is seeking for a Logistics Quality Coordinator to be part of their Quality Control Team (Permanent opportunity). 3+ year experience required.
- Quality Assurance
- CAPA System
- Audit Process
- SOP Development
Logistics Quality Coordinator Responsibilities include:
- Implement, communicate and maintain company’s quality systems at MIA logistics, in compliance with company Global quality management system requirements.
- Agree standards and define quality processes and procedures through effective controlled document issue and management.
- Liaise with clients on Quality Assurance and client 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 organization from previous customer audits.
- Host client audits and regulatory inspections and manage the audit report responses. Acting as organization'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 Miami location.
- Ensuring that the Quality System and GDP Program are implemented and maintained.
- Assisting in the evaluation of designated vendors and/or out-sourced activities.
- Ensuring the accuracy and quality of records and documents.
Key Competencies for Quality Coordinator:
- Excellent communication
- Self-motivated, work independently and able to meet deadlines
- Excellent customer service orientation
- Great interpersonal skills
- Problem analysis and problem-solving
- Must have strong oral and written communication, problem solving and interpersonal skills in English and Spanish
- Great attention to detail