Quality Client Representative

Company: BAXTER
Location: Bloomington
Posted on: April 8, 2021

Job Description:

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.-Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.-Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.-The Quality Client Representative is a member of the core client team and interacts directly with clients.- The Quality Client Representative is responsible for all quality aspects of the project and provides exemplary customer service to both internal and external customers by focusing on quality and compliance.- This position reports to the Manager II, Quality- Proprietary Products.Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):

• Primary quality contact for assigned clients externally and internally.
• Manages client project quality updates and reviews with all levels of management.
• Responsible for making and delivering accurate and timely quality decisions pertaining to client projects, questions, and quality requests.
• Escalates quality issues to impacted departmental quality manager and/or Quality Director as necessary for corrective action implementation.
• Partners with manager and Quality leadership staff to author, drive or approve applicable quality documents, as the Quality representative in a timely manner.
• Partners with Program Manager, Technical Services Representatives, Quality Control Representative and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information.
• Represents Quality in required Project Client Meetings.-
• Understands the quality and technical requirements of each project.
• Maintains Project File, including recording and tracking quality interaction with client. Track, trend, compile and report client quality metrics as necessary.
• Thoroughly understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product.
• Assist and lead quality agreement contract negotiations
• Identifies and leads continuous improvement activities to maximize business results.Job Requirements (Education, Experience and Qualifications):
  • Bachelor's degree required, preferably in a science related field.
  • Minimum 5 years pharmaceutical industry experience.
  • Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality.
  • Knowledge of worldwide regulatory requirements
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:- JDE, BPLM, Pilgrim, Trackwise, etc.)Physical / Safety Requirements:
    • Duties may require overtime work, including nights and weekends
    • Use of hands and fingers to manipulate office equipment is required
    • Position may require sitting or standing for long hours of time.-Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
      
      
      
      Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

Keywords: BAXTER, Bloomington , Quality Client Representative, Other , Bloomington, Indiana