Associate I, Quality

Your role at Baxter

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.

What we offer from day 1

• 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

What you'll be doing

• 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.

What you'll bring

• 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.

• 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.

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 $64,000.00 - $88,000.00 USD 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.

Join our dedicated team at Baxter Healthcare Corporation and be part of our mission to improve healthcare outcomes for patients worldwide. Apply today and take the next step in your career!

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