Associate , Quality

Job Description

This is where your 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.

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.

• Paid Time Off and Paid Holidays

• Medical, Dental, Disability and Life Insurance coverage

• Vision and Voluntary Benefits

• Paid Parental Leave

• Retirement Savings Plan

• Employee Stock Purchase Program

• Flexible Health Care Spending Accounts

• Educational Assistance Plan

• 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.

• Bachelor's degree or Associate degree required.

• Minimum one year of relevant…