Documentation Specialist

Baxter International Inc.; Round Lake (IL); On-site; USD 49,000 - 68,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

ESPP

Paid time off

Job summary

Baxter International Inc. is seeking a Documentation Specialist to support manufacturing by reviewing batch records and GMP documentation to ensure compliance with cGMP, Baxter policies, and local procedures.

You will help maintain the integrity of manufacturing records, ensuring they are complete, accurate, and ready for product release. Working closely with Manufacturing and Quality teams, you will handle documentation review processes, investigations, and document control activities to

Qualifications

• Associate degree or 3+ years of experience in a manufacturing and/or quality documentation environment.
• Experience with GMP documentation, GDP, and cGMP standards.
• Familiarity with quality systems, investigations and document control processes.

Responsibilities

• Review manufacturing batch records and GMP documentation for cGMP compliance.
• Verify records meet specifications prior to submission to Quality.
• Ensure documentation is complete and organized before batch folder submission.
• Maintain and file documentation for easy retrieval.
• Initiate and close GME work orders and NCRs as needed.
• Support GME cycle counting and continuous improvement initiatives.

Skills

Attention to detail

Microsoft Office

Verbal and written communication

Independent worker

Multitasking

Education

Associate degree

Tools

Maximo

SYSTECH

Job description

This is whereyour work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from - deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Your role at Baxter

As a Documentation Specialist, you will provide critical support to manufacturing operations by reviewing batch records and GMP documentation to ensure compliance with current Good Manufacturing Practices (cGMP), Baxter policies, and local procedures. You will help maintain the integrity of manufacturing documentation by ensuring records are complete, accurate, and submitted on schedule to support product release activities.

This is where your attention to detail and commitment to quality will directly impact operational efficiency and regulatory compliance. Working closely with Manufacturing and Quality teams, you will support documentation review processes, investigations, and document control activities that help ensure the safe and effective production of Baxter products.

What you'll be doing

• Review manufacturing batch records and other GMP documentation to ensure compliance with cGMP requirements, company policies, and local SOPs.
• Support manufacturing batch documentation review and ensure records meet specifications prior to submission to Quality.
• Verify batch documentation complies with Good Documentation Practice (GDP) standards.
• Determine document acceptability using specifications, procedures, and established standards.
• Ensure all required documentation is complete and present prior to batch folder submission.
• Maintain documentation files to ensure records are organized, readily available, and easily retrievable.
• Initiate and close GME work orders.
• Author Non-Conformance Records (NCRs) and exception investigations.
• Author and maintain TCU documentation, including revisions, periodic reviews, and gap assessments.
• Utilize Maximo to print, assign, and track preventative maintenance work orders to completion.
• Use SYSTECH to review and approve batch counts.
• Initiate batch folders through required system data entry activities.
• Support GME cycle counting activities as required.
• Identify opportunities for continuous improvement and support additional administrative duties as assigned.

What you'll bring

• Associate degree or 3+ years of experience in a manufacturing and/or quality documentation environment.
• Must not be allergic to Penicillin or Cephalosporin drugs.
• Proficiency with Microsoft Office applications.
• Strong attention to detail and organization skills.
• Ability to work independently and manage multiple priorities.
• Effective verbal and written communication skills.
• Flexibility to work overtime or adjusted schedules based on business needs.
• Experience reviewing batch records and GMP documentation.
• Knowledge of cGMP and Good Documentation Practices (GDP).
• Experience with quality systems, investigations, and document control processes.
• Experience using Maximo, SYSTECH, or similar manufacturing systems.
• Continuous improvement mindset with strong problem-solving skills

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is 49,000 - $68,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors . For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.