Quality Associate

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 Associate I is responsible for providing Quality support to the Global Logistics Center. Inspects products, initiates and updates procedures, reviews temperature monitoring data, and ensures compliance with GMP/QSRs requirements, according to corporate and local Standard Operating Procedures, and all applicable FDA and state regulations.

Job Responsibilities

• Perform physical inspection of products and comparison/assessment to all related documentation within the warehouse as needed (certificate or analysis, packing list, bill of lading, Temptale management, etc.)
• Initiate procedure revisions as needed to support continuous improvement.  Ensure that procedures are current and that facility employees perform tasks according to procedures through direct observation.
• Activate, distribute and file procedures related to both local and corporate changes.
• Manage official forms distributed throughout the facility.
• Support assigned activities to ensure compliance with the Baxter COI program.
• Collaborate with the Training Administrator to ensure training requirements are met prior to activation of all procedures.
• Manage the state licensure program to ensure no licenses expire.
• Support Temperature Monitoring of the MGLC Warehouse which includes operating the Rees system, reporting all temperatures on a spreadsheet for daily management review and uploading data from the backup digital data loggers throughout the facility.  Investigate and resolve any Rees system alarms and document monthly MKT requirements.
• Manage the document retention program.
• Support assigned responsibilities for document tracking and overall facility documentation control.
• Prepare monthly Quality Management & Data Review Presentations.
• Perform Internal Assessments for continuous improvement of MGLC Quality Systems.
• Assist other members of the Quality Department and facility management team to ensure timely closure of any audit observations.
• Serve as a back-up for processing local hold requests using the Warehouse Management System (WMS) and JD Edwards (JDE) systems as needed.
• Serve as a back-up for processing corporate FCA hold requests using Cardinal Health’s FCA Tracking System, Baxter’s Warehouse Management System (WMS) and Baxter’s JD Edwards (JDE) system.  Conduct audits of FCA hold product.
• Serve as a back-up for processing product dispositions linked to local and corporate holds and report through the appropriate people and systems to ensure timely response/closure.
• Perform manual product releases after verification of release by manufacturing plant in Batch Release System (BRS) as necessary.
• Support all lean implementation initiatives in the Quality Department and throughout the facility, including periodic 6S audits and closure of any assigned action items.
• Work in collaboration with other members of the Quality Department to prepare for internal and external auditors.
• Support the Quality Department by completing other duties, projects and/or tasks that may be assigned as needed.

Qualifications

• Strong interpersonal skills and great attention to detail are necessary.
• Must be able to handle multiple projects concurrently.
• Knowledge of FDA Regulations, Application of Good Manufacturing Practices.
• Must be a strong team player with good problem solving and good verbal and written communication skills.

Education and Experience

• Bachelor's degree or Associate degree required.
• Minimum one year of relevant experience.
• Experience with a medical device/pharma or other similarly regulated industry preferred.

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.
                                                                                                                                                               
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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

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