Associate I, Quality

Baxter•Byhalia, MS

4d•$64,000 - $88,000

About The Position

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. Job Description 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

Requirements

Bachelor's degree or Associate degree required.
Minimum one year of relevant experience.
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.

Nice To Haves

Experience with a medical device/pharma or other similarly regulated industry preferred.

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.

Benefits

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
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.
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.