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Baxter Documentation Specialist in Bloomington, Indiana

Documentation Specialist

Req # JR - 034958

Location Bloomington, Indiana

Job Category Quality Control

Date posted 02/18/2021

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 Documentation Specialist assists in preparing and/or maintaining Quality System documentation to support operations. He or she is responsible for batch record issuance and receipt and archival of executed Batch records and other quality documentation generated during manufacturing and finishing operations. He or she performs review of all quality documentation generated during support section review. This position is also responsible for applying and removing Quality Holds. He or she is responsible for maintaining and ensuring accuracy of the hold system. He or she provides customer service to internal customers, as well as communicates effectively with all levels of the organization.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):

  • Perform batch record review for GMP support sections produced at Baxter for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.

  • Reconcile discrepancies with documentation and/or electronic systems as appropriate.

  • Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.

  • Complete hold documentation and complete actions in the Trackwise systems

  • Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.

  • Perform batch record issuance tasks Job Requirements (Education, Experience and Qualifications):

  • High school diploma or GED required

  • Associates degree preferred

  • Minimum 2 years experience with documentation and/or change control systems

  • 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

  • Occasionally required to lift and/or move objects (boxes, totes, etc.) weighing 25 pounds

  • Duties may require overtime work, including nights and weekends

  • Use of hands and fingers to manipulate office equipment is required

  • Position requires sitting for long hours but may involve walking or standing for periods of time.

Equal Employment Opportunity

Baxter 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.

EEO is the Law

EEO is the law - Poster Supplement

Pay Transparency Policy

Reasonable Accommodations

Baxter 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[email protected]and let us know the nature of your request along with your contact information.