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Quality System Coordinator

Req #: 180001ZR_en
Location: St Paul, MN US
Job Category: Quality
Date Posted: 1/31/2018 3:41:44 PM
Baxter International

Description

About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

 
Quality System Coordinator or Quality Associate II
Description
This position is responsible for serving as subject matter expert for assigned Quality Systems processes, including but not limited to, Document Management, document change control for product, process, and QMS documents. This position is also responsible for serving as the local training administrator for 2 Baxter sites. In addition, this position is a key member of the internal/external audit readiness team.
 
Essential Duties & Responsibilities
  • Act as local site administrator and subject matter expert for learning system, to include creation/assignment of training courses/modules/curricula and recording training completion data
  • Maintain accurate training records and metrics that provide evidence of completion of the assigned required training that is necessary for competent job performance and the health of the training system.
  • Take leadership and/or subject matter expert role in normal day-to-day activities, routine and special projects, and continuous improvement efforts supporting assigned Quality Systems processes, e.g. document change control
  • Coach and assist other employees whose roles and responsibilities require them to work within the Quality System and meet Quality System process requirements
  • Create, update and maintain procedures and any other documentation for assigned Quality Systems processes.
  • Establish and maintain, trend, and report data/metrics for assigned Quality Systems processes
  • Identify and work on Quality Systems process improvement projects
  • Interact regularly with peers in Quality Systems and other functional areas locally and at corporate and other manufacturing sites level
  • Participate in regulatory and / or internal audits as needed

Qualifications

Qualifications
  • Ability to administer all required automated electronic system functions for assigned Quality Systems processes
  • Ability to administer all required Learning Management Systems functions and serve as site subject matter expert
  • Ability to adapt and implement training to support changes in work processes and systems
  • Effective presentation skills and group facilitation skills. Ability to communicate clearly and accurately in both verbal and written form in all job-related activities
  • Knowledge and application of Good Manufacturing Practices (GMP). Knowledge of applicable procedures, specifications, regulations and standards.
  • Strong analytical skills and process orientation
  • Strong influencing and negotiating skills
  • Ability to work effectively with all levels of the organization, and work with minimal supervision
  • Ability to manage workload effectively
  • Ability to collaborate effectively
  • Good project management skills
  • Good problem-solving skills
  • Computer proficiency including use of standard business productivity software (e.g., Microsoft Office applications)
Education & Experience
  • Undergraduate 4-year degree in science, engineering, or other academic discipline that supports role and responsibilities; or equivalent professional experience.
  • 3-5 years of experience in Quality, or related field in the medical products or other regulated industry.
  • Working knowledge of, and effective interpretation and application of, Quality Systems regulations and ISO requirements.
Physical Demands
  • Frequent standing/walking.
  • Ability to sit/stand at computer workstation and use computer keyboard to enter data, develop materials, etc.
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