Documentation Specialist Group Leader - Manufacturing [1St Shift]

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.

Summary

The Documentation Specialist Group Leader performs all the functions of a Documentation Specialist, including the review of executed documentation for the Manufacturing department, ensuring compliance to current Good Manufacturing Practices and Good Documentation Practices, working to resolve identified corrections and managing the timely completion of record review and submission to Quality Assurance. The Documentation Specialist Group Leader also oversees the day-to-day operations of the Documentation Specialist department by prioritizing tasks, managing investigations, and ensuring KPIs are appropriately tracked and reported. This position reports to a Mgr II, Manufacturing.

Essential Duties and Responsibilities:

• Coordinate, organize and perform production review of designated manufacturing batch records to ensure the safety and reliability of Baxter products, and to comply with quality and regulatory requirements
• Form partnerships with other business functions (e.g. Quality Assurance, Technical Services, and Finishing) in order to achieve internal targets and contractual commitments for batch release
• Identify and prevent potential non-conformance issues
• Perform cursory review of in-process batch-related documentation. Reviews will be performed inside classified manufacturing workspaces.
• Maintain and report applicable documentation review and submission metrics.
• Support department lean initiatives and provide input to improve processes.
• Lead continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.
• Manage manufacturing documentation centers, including flow of documents, corrections, final review and submission of records to quality assurance to meet designated timelines.
• Act as lead for all documentation specialists ensuring department priorities are aligned with site goals and schedule- this includes nonconformance management of team as well as documentation review of executed batches in a timely manner.

Job Requirements (Education, Experience and Qualifications):

• High School diploma or GED required
• Two years of manufacturing experience preferred.
• Experience with pharmaceutical regulations preferred, including current Good Manufacturing Practices and current Good Documentation Practices
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
• Ability to write legibly
• Previous leadership experience, preferred.

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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $41,500 to $120,000 and also includes an annual incentive bonus, commission target, and/or equity target (strike any, if not applicable). The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location

Physical Demands:

• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position may require standing or sitting for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Must be able to gown qualify for Grade C/D areas.
• Must be able to gown qualify for Grade B areas.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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 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.